Product Code: MQB FDA class 2 21 CFR 892.1680

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

The Solid State X-Ray Imager (Flat Panel/Digital Imager) is a radiology device that uses solid-state detector technology to convert X-ray energy directly into digital images, replacing traditional film or image intensifiers and providing high-quality digital radiographic images. Classified as FDA Class 2 under 21 CFR 892.1680, it requires 510(k) premarket notification. The product code is MQB, and it is eligible for third-party 510(k) review.

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510(k)s

423

FEI Numbers

126

Registration Numbers

126

Unique Applicants

131

Years Active

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Basic Information

Product Code: MQB
Device Class: FDA class 2
Regulation Number: 892.1680
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 423 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260820	VIVIX-S 4386W (FXRD-4386WA)	Jun 18, 2026	Substantially Equivalent	Vieworks Co., Ltd.
K252996	Universal 1417PI	Jun 12, 2026	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K252911	Lux HD 2530 detector (Lux HD 2530)	Oct 09, 2025	Substantially Equivalent	Iray Imaging Technology (Haining) Limited
K250211	Yushan X-Ray Flat Panel Detector	Jul 22, 2025	Substantially Equivalent	Innocare Optoelectronics Corp.
K250665	SKR 3000	Jun 17, 2025	Substantially Equivalent	Konica Minolta, Inc.
K243734	Wireless/ Wired X-Ray Flat Panel Detectors	Apr 18, 2025	Substantially Equivalent	Allengers Medical Systems Limited
K242770	EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG	Mar 20, 2025	Substantially Equivalent	DRTECH Corporation
K243443	EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP	Mar 19, 2025	Substantially Equivalent	DRTECH Corporation
K243556	Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)	Mar 18, 2025	Substantially Equivalent	Iray Imaging Technology (Haining) Limited
K244010	ExamVue Apex	Feb 24, 2025	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K243171	Yushan X-Ray Flat Panel Detector	Dec 19, 2024	Substantially Equivalent	Innocare Optoelectronics Corp.
K241319	SKR 3000	Nov 21, 2024	Substantially Equivalent	Konica Minolta, Inc.
K241125	VIVIX-S 1751S	Nov 15, 2024	Substantially Equivalent	Vieworks Co., Ltd.
K240771	PRORAD X-Ray Flat Panel Detector with DROC	Nov 12, 2024	Substantially Equivalent	Prognosys Medical Systems Private Limited
K241346	IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)	Nov 07, 2024	Substantially Equivalent	Aspen Imaging Healthcare, Inc.
K242394	Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)	Sep 09, 2024	Substantially Equivalent	Rayence Co., Ltd.
K240371	0909FCC, 0909FCC-HS	Mar 07, 2024	Substantially Equivalent	Rayence Co., Ltd.
K232082	EXPD 4343S	Feb 13, 2024	Substantially Equivalent	DRTECH Corporation
K232753	EXPD 4343D; EXPD 3643D	Nov 16, 2023	Substantially Equivalent	DRTECH Corporation
K230918	MasterX 800 Series	Sep 01, 2023	Substantially Equivalent	Medicatech USA
K232058	YosemiteView 4343W/YosemiteView 3643W	Aug 03, 2023	Substantially Equivalent	Careray Digital Medical Technology Co., Ltd.
K231959	EXPD 4357; EXPD 4357P	Aug 01, 2023	Substantially Equivalent	DRTECH Corporation
K231709	AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4	Jul 12, 2023	Substantially Equivalent	Radmedix, LLC
K231467	1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF	Jun 21, 2023	Substantially Equivalent	Rayence Co., Ltd.
K223930	A1417MCW/A1717MCW/F1417MCW	Mar 06, 2023	Substantially Equivalent	H&abyz Co., Ltd.
K230175	Digital Radiography CXDI-CS01	Feb 15, 2023	Substantially Equivalent	Canon, Inc.
K230059	Digital Flat Panel Detector	Feb 03, 2023	Substantially Equivalent	Ray Imaging Technology (Haining) Limited
K223546	14HQ721G-B	Jan 27, 2023	Substantially Equivalent	Lg Electronics.Inc
K223687	X-ray Flat Panel Detectors (EverestView 4343X)	Dec 30, 2022	Substantially Equivalent	Careray Digital Medical Technology Co., Ltd.
K223009	Wireless/Wired X-Ray Flat Panel Detectors	Nov 27, 2022	Substantially Equivalent	Allengers Medical Systems Limited
K223124	EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG	Nov 18, 2022	Substantially Equivalent	DRTECH Corporation
K223267	SKR 3000	Nov 17, 2022	Substantially Equivalent	Konica Minolta, Inc.
K222886	Mercu 1717V	Oct 20, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K222855	Digital Radiography CXDI-Pro, Digital Radiography D1	Oct 17, 2022	Substantially Equivalent	Canon, Inc.
K222687	Digital Radiography CXDI-Elite, Digital Radiography E1	Sep 29, 2022	Substantially Equivalent	Canon, Inc.
K222661	Digital Radiography CXDI-CS01	Sep 27, 2022	Substantially Equivalent	Canon, Inc.
K220239	Solid State X-ray Imager(Model: FXRD-4386WB)	Sep 13, 2022	Substantially Equivalent	Vieworks Co., Ltd.
K221549	X-ray Flat Panel Detectors (CareView 1800 RF)	Aug 01, 2022	Substantially Equivalent	Careray Digital Medical Technology Co., Ltd.
K221461	10HQ701G-B	Jul 22, 2022	Substantially Equivalent	Lg Electronics.Inc
K221394	14HQ701G-B	Jul 22, 2022	Substantially Equivalent	Lg Electronics.Inc
K221512	Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)	Jul 20, 2022	Substantially Equivalent	Vieworks Co., Ltd.
K221876	Digital Radiography CXDI-Pro, Digital Radiography D1	Jul 15, 2022	Substantially Equivalent	Canon, Inc.
K221434	17HQ701G-B	Jul 13, 2022	Substantially Equivalent	Lg Electronics.Inc
K221714	Flat Panel Detector	Jun 29, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K221345	Wireless Digital Flat Panel Detector	Jun 16, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K221620	Digital Radiography CXDI-Elite, Digital Radiography E1	Jun 14, 2022	Substantially Equivalent	Canon, Inc.
K221144	PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG	May 13, 2022	Substantially Equivalent	Radisen Co., Ltd.
K220559	17HQ901G-B	May 05, 2022	Substantially Equivalent	Lg Electronics.Inc
K220536	Digital flat panel detector	Apr 28, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K220510	Yushan X-Ray Flat Panel Detector with DROC	Apr 14, 2022	Substantially Equivalent	Innocare Optoelectronics Corp.
K220668	Wireless Digital Flat Panel Detector	Apr 01, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K213646	Focus HD 35 Detector	Mar 29, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K213529	Focus HD 43 Detector	Mar 29, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K214044	14HQ901G-B	Feb 16, 2022	Substantially Equivalent	Lg Electronics.Inc
K220098	Digital Radiography CXDI-Pro, Digital Radiography D1	Feb 04, 2022	Substantially Equivalent	Canon, Inc.
K213908	SKR 3000	Jan 31, 2022	Substantially Equivalent	Konica Minolta, Inc.
K213780	DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1	Jan 24, 2022	Substantially Equivalent	Canon, Inc.
K214030	Universal DR 1748	Jan 21, 2022	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K213307	Eclipse II with Smart Noise Cancellation	Jan 14, 2022	Substantially Equivalent	Carestream Health, Inc.
K213469	VALORY	Nov 18, 2021	Substantially Equivalent	Agfa N.V.
K213497	ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)	Nov 15, 2021	Substantially Equivalent	H&abyz Co., Ltd.
K212753	0909FCB, 1212FCA	Oct 18, 2021	Substantially Equivalent	Rayence Co., Ltd.
K212269	Intelligent NR	Sep 17, 2021	Substantially Equivalent	Canon, Inc.
K212553	DIGITAL RADIOGRAPHY CXDI-Pro, D1	Sep 09, 2021	Substantially Equivalent	Canon, Inc.
K212051	RFA-1717DIG, RFA-1717DIC	Aug 25, 2021	Substantially Equivalent	Astel, Inc.
K210619	SKR 3000	Aug 24, 2021	Substantially Equivalent	Konica Minolta, Inc.
K212105	6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF	Aug 23, 2021	Substantially Equivalent	Pzmedical Technology Co., Ltd.
K211790	DX-D Imaging Package with XD Detectors	Jul 30, 2021	Substantially Equivalent	Agfa N.V.
K211542	PRIMO S	Jul 09, 2021	Substantially Equivalent	A.T.S. Applicazione Tecnologie Speciali S.R.L.
K211108	Prudent 1717, Prudent 1417, Prudent 1212	Jun 04, 2021	Substantially Equivalent	Pixxgen Corporation
K210919	AcuityDRe	Apr 30, 2021	Substantially Equivalent	Radmedix, LLC
K210985	1717FCC	Apr 28, 2021	Substantially Equivalent	Rayence Co., Ltd.
K210988	Yushan X-Ray Flat Panel Detector with DROC	Apr 21, 2021	Substantially Equivalent	Innocare Optoelectronics Corp.
K202441	Eclipse II with Smart Noise Cancellation	Apr 02, 2021	Substantially Equivalent	Carestream Health, Inc.
K203703	I-Q View	Mar 24, 2021	Substantially Equivalent	First Source, Inc.
K203188	ADD	Mar 12, 2021	Substantially Equivalent	H&abyz Co., Ltd.
K210316	Mars 1417X Wireless Digital Flat Panel Detector	Mar 03, 2021	Substantially Equivalent	Iray Technology Taicang , Ltd.
K210314	Mars1717X Wireless Digital Flat Panel Detector	Mar 02, 2021	Substantially Equivalent	Iray Technology Taicang , Ltd.
K202995	X-ray Flat Panel Detectors/CareView 3600RF	Feb 19, 2021	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K203849	General Radiography CXDI-CS01	Jan 26, 2021	Substantially Equivalent	Canon, Inc.
K203159	Lux 35 Detector	Dec 02, 2020	Substantially Equivalent	Carestream Health
K202722	1212FCA	Oct 26, 2020	Substantially Equivalent	Rayence Co., Ltd.
K201528	Yushan X-Ray Flat Panel Detector with DROC	Oct 11, 2020	Substantially Equivalent	Innocare Optoelectronics Corp.
K202564	DigitalDiagnost C90	Sep 30, 2020	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K201591	Flat Panel Detector	Sep 03, 2020	Substantially Equivalent	Ka Imaging, Inc.
K201932	X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)	Aug 07, 2020	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K201796	1717SCV, 1717SGV	Jul 23, 2020	Substantially Equivalent	Rayence Co., Ltd.
K201503	Edge Air(1417) Digital Flat Panel X-ray Detector	Jun 29, 2020	Substantially Equivalent	Osko, Inc.
K201247	Intraoral Sensor	Jun 10, 2020	Substantially Equivalent	Dentium Co., Ltd (Ict Branch)
K201043	Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)	May 12, 2020	Substantially Equivalent	Iray Technology Taicang , Ltd.
K201058	Accuvue+	May 06, 2020	Substantially Equivalent	Radmedix, LLC
K201004	Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W	May 01, 2020	Substantially Equivalent	Iray Technology Taicang , Ltd.
K200787	BSD3543W	Apr 23, 2020	Substantially Equivalent	Bontech Co., Ltd.
K200668	DR-ID 1200SDK System	Apr 10, 2020	Substantially Equivalent	Fujifilm Corporation
K200622	Focus 43C detector, TRIMAX 43C detector	Apr 01, 2020	Substantially Equivalent	Iray Technology Taicang , Ltd.
K200418	VIVIX-S VW	Mar 18, 2020	Substantially Equivalent	Vieworks Co., Ltd.
K192894	Vita Flex CR System with LLI	Feb 18, 2020	Substantially Equivalent	Carestream Health, Inc.
K193644	E-COM DR-2000 DR	Feb 14, 2020	Substantially Equivalent	Livermoretech, Inc.
K200018	HAD1717MC	Jan 31, 2020	Substantially Equivalent	H&Abyz
K193238	Nexus DR Digital X-Ray Imaging System (with vSharp)	Dec 20, 2019	Substantially Equivalent	Varex Imaging Corporation
K193173	CareView 1800Le	Dec 13, 2019	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K193031	EXPD 4343P, EXPD 3643P	Nov 22, 2019	Substantially Equivalent	DRTECH Corporation
K193017	EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP	Nov 22, 2019	Substantially Equivalent	DRTECH Corporation
K192932	FDR D-EVO III flat panel detector system	Nov 12, 2019	Substantially Equivalent	Fujifilm Corporation
K192632	DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless	Nov 07, 2019	Substantially Equivalent	Canon, Inc.
K192440	FDR SE Lite	Nov 01, 2019	Substantially Equivalent	Fujifilm Corporation
K192512	Focus 35C Detector, Trimax 35C Detector	Oct 16, 2019	Substantially Equivalent	Iray Technology Taicang , Ltd.
K192400	EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG	Oct 03, 2019	Substantially Equivalent	DRTECH Corporation
K191939	Yushan X-Ray Flat Panel Detector	Aug 29, 2019	Substantially Equivalent	Innocare Optoelectronics Corp.
K191645	SKR 4000	Aug 16, 2019	Substantially Equivalent	Konica Minolta, Inc.
K190611	VIVIX-S 1751S	Apr 08, 2019	Substantially Equivalent	Vieworks Co., Ltd.
K190691	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	Apr 04, 2019	Substantially Equivalent	Pixxgen Corporation
K190368	Enhanced Feature Software Pack CXDI Series	Mar 13, 2019	Substantially Equivalent	Canon, Inc.
K190311	BIOK7600 Flat Panel Detector	Mar 13, 2019	Substantially Equivalent	Biokinemetrics, Inc.
K190300	BIOK7600W Wireless Flat Panel Detector	Mar 13, 2019	Substantially Equivalent	Biokinemetrics, Inc.
K190146	Nexus DR Digital X-ray Imaging System	Mar 08, 2019	Substantially Equivalent	Varex Imaging Corporation
K183245	Carestream DRX-1 System with DRX Plus 2530 Detectors	Feb 08, 2019	Substantially Equivalent	Carestream Health, Inc.
K183474	Carestream DRX-1 System with DRX Core Detectors	Jan 16, 2019	Substantially Equivalent	Carestream Health, Inc.
K182973	DigitalDiagnost C90	Jan 11, 2019	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K183713	Wireless Digital Flat Detector	Jan 09, 2019	Substantially Equivalent	Iray Technology Taicang , Ltd.
K183422	Wireless Digital Flat Panel Detector	Jan 09, 2019	Substantially Equivalent	Iray Technology Taicang , Ltd.
K182688	SKR 3000	Dec 18, 2018	Substantially Equivalent	Konica Minolta, Inc.
K183286	17HK701G-W	Dec 07, 2018	Substantially Equivalent	Lg Electronics.Inc
K183212	Nexus DR Digital X-ray Imaging System with stitching	Dec 07, 2018	Substantially Equivalent	Varex Imaging Corporation
K182348	14HK701G-W	Oct 18, 2018	Substantially Equivalent	Lg Electronics.Inc
K182551	Wireless Digital Flat Panel Detector	Oct 17, 2018	Substantially Equivalent	Iray Technology Taicang , Ltd.
K182550	Wireless Digital Flat Panel Detector	Oct 17, 2018	Substantially Equivalent	Iray Technology Taicang , Ltd.
K182533	PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels	Oct 04, 2018	Substantially Equivalent	Pixxgen Corporation
K181631	GR40CW	Jul 20, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K181565	Aquarius 8600 Digital Radiography Sensor	Jul 13, 2018	Substantially Equivalent	Biokinemetrics, Inc.
K181526	XRpad2 4343 HWC-M Flat Panel Detector	Jul 03, 2018	Substantially Equivalent	Varex Imaging Corporation
K180809	Eclipse II	Jun 21, 2018	Substantially Equivalent	Carestream Health, Inc.
K180989	PEDRA-17F Digital Flat Panel X-ray Detector	Jun 13, 2018	Substantially Equivalent	Radisen, Inc.
K180332	17HK700G-W	Jun 08, 2018	Substantially Equivalent	Lg Electronics
K180976	PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels	May 24, 2018	Substantially Equivalent	Pixxgen Corporation
K181003	VIVIX-S 1717V	May 15, 2018	Substantially Equivalent	Vieworks Co., Ltd.
K180667	SmartGrid	Apr 13, 2018	Substantially Equivalent	Carestream Health, Inc.
K171270	DIGITAL RADIOGRAPHY CXDI-410C WIRELESS	Nov 17, 2017	Substantially Equivalent	Canon, Inc.
K173273	Aquarius 8600 1417WCI; Aquarius 8600 1717WCI	Nov 09, 2017	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K172124	Televere Podiatry Digital Imaging System	Nov 09, 2017	Substantially Equivalent	Televere Systems
K172951	Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)	Oct 24, 2017	Substantially Equivalent	Varex Imaging Corporation
K172784	DX-D Imaging Package	Oct 13, 2017	Substantially Equivalent	Agfa Healthcare N.V.
K172435	Galaxy R Digital Radiography Upgrade	Oct 13, 2017	Substantially Equivalent	Medien International Co, Ltd.
K172793	SKR 3000	Oct 12, 2017	Substantially Equivalent	Konica Minolta, Inc.
K171169	Aquarius 8600 1417TG and Aquarius 8600 1717TG	Oct 12, 2017	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K172682	Edge Digital Flat Panel X-ray Detector	Oct 06, 2017	Substantially Equivalent	Osko, Inc.
K172681	Edge Air Digital Flat Panel X-ray Detector	Oct 06, 2017	Substantially Equivalent	Osko, Inc.
K171175	Aquarius 8600 1417WC	Oct 05, 2017	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K172581	CareView 1800Cw X-ray Flat Panel Detectors	Sep 26, 2017	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K171716	SKR 3000	Aug 25, 2017	Substantially Equivalent	Konica Minolta, Inc.
K171461	SkyPlate Detector for Philips Radiography/Fluoroscopy Systems	Jul 07, 2017	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K170480	Models 3543A, 4343A, 2929A and A843B	Jul 07, 2017	Substantially Equivalent	Shanghai PZ Medical Technolgoy Co., Ltd.
K163624	Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)	Jun 30, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K171485	BSD4343R Digital Flat Panel X-ray Detector	Jun 21, 2017	Substantially Equivalent	Bontech, Inc.
K171418	1417WCC_127um and1417WCC_140um	Jun 12, 2017	Substantially Equivalent	Rayence Co., Ltd.
K171417	1417WGC_127um and 1417WGC_140um	Jun 12, 2017	Substantially Equivalent	Rayence Co., Ltd.
K171420	1717SCC_127um and 1717SCC_140um	Jun 09, 2017	Substantially Equivalent	Rayence Co., Ltd.
K171419	1717SGC_127um and 1717SGC_140um	Jun 09, 2017	Substantially Equivalent	Rayence Co., Ltd.
K171138	Nexus DR Digital X-ray Imaging System	May 17, 2017	Substantially Equivalent	Varex Imaging Corporation
K171137	EVS 2430W, EVS 2430GW	May 15, 2017	Substantially Equivalent	DRTECH Corporation
K171085	GMR40	May 11, 2017	Substantially Equivalent	Neurologica Corporation, A Subsidiary OF
K170975	Televere Digital Imaging System	May 01, 2017	Substantially Equivalent	Televere Systems
K163157	SmartGrid	Mar 21, 2017	Substantially Equivalent	Carestream Health
K170332	DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS	Mar 01, 2017	Substantially Equivalent	Canon, Inc.
K170202	Aquarius 8600	Feb 22, 2017	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K170113	pixium 4343RCE	Feb 09, 2017	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K163703	VIVIX-S 1417N	Feb 08, 2017	Substantially Equivalent	Vieworks Co., Ltd.
K162909	CSX-30 Flat Panel Detector	Jan 27, 2017	Substantially Equivalent	Canon, Inc. Medical Equipment Group
K162555	EVS 4343, EVS 4343G	Dec 21, 2016	Substantially Equivalent	DRTECH Corporation
K162344	INNOLUX RIC	Dec 20, 2016	Substantially Equivalent	Innolux Corporation
K161730	Wireless Digital Flat Panel Detector	Dec 08, 2016	Substantially Equivalent	Iray Technology (Shanghai) , Ltd.
K162552	EVS 3643, EVS 3643G	Dec 02, 2016	Substantially Equivalent	DRTECH Corporation
K163019	CareView 750Cw/750C X-ray Flat Panel Detectors	Dec 01, 2016	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K160143	ClearVision ExamVue Flat Panel Detector	Oct 28, 2016	Substantially Equivalent	Jpi Healthcare, Inc.
K162487	BSD3543 Digital Flat Panel X-ray Detector	Oct 14, 2016	Substantially Equivalent	Bontech, Inc.
K162519	1717WCC / 1717WGC	Oct 06, 2016	Substantially Equivalent	Rayence Co., Ltd.
K162518	1012WCC, 1012WGC	Oct 06, 2016	Substantially Equivalent	Rayence Co., Ltd.
K162504	SKR 3000	Oct 03, 2016	Substantially Equivalent	Konica Minolta, Inc.
K161368	DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)	Sep 22, 2016	Substantially Equivalent	Agfa Healthcare N.V.
K161966	PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector	Sep 08, 2016	Substantially Equivalent	Perkinelmer, Inc.
K161459	Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)	Sep 06, 2016	Substantially Equivalent	Varian Medical Systems, X-Ray Products-Infimed
K162178	CareView 1500P X-ray Flat Panel Detectors	Sep 01, 2016	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K161942	PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector	Sep 01, 2016	Substantially Equivalent	Perkinelmer, Inc.
K153312	SCATTER CORRECTION FOR CXDI SERIES	Jun 28, 2016	Substantially Equivalent	Canon, Inc.
K160204	BSD4343 Digital Flat Panel X-ray Detector	Jun 09, 2016	Substantially Equivalent	Bontech, Inc.
K160810	ViZion DR + Wireless	May 20, 2016	Substantially Equivalent	Viztek, LLC
K153464	FDR D-EVO flat Panel Detector System	Apr 08, 2016	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K153710	Tuxedo Digital Dental Sensor	Mar 18, 2016	Substantially Equivalent	Led Dental, Inc.
K152894	VIVIX-S 1717N	Feb 26, 2016	Substantially Equivalent	Vieworks Co., Ltd.
K152855	VIVIX-S 1012N	Feb 26, 2016	Substantially Equivalent	Vieworks Co., Ltd.
K153492	CareView 1800L	Dec 24, 2015	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K153318	Philips Eleva Workspot with SkyFlow	Dec 22, 2015	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K153401	GR40CW	Dec 21, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K152639	DR 600	Dec 11, 2015	Substantially Equivalent	Agfa Healthcare N.V.
K153142	Carestream DRX-1 System with DRX Plus 4343 Detectors	Nov 25, 2015	Substantially Equivalent	Carestream Health, Inc.
K153058	CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors	Nov 10, 2015	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K152151	ATAL 9	Nov 10, 2015	Substantially Equivalent	Atlaim Corporation
K152138	FDR D-EVO GL Flat Panel Detector System	Nov 05, 2015	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K151942	EVS 3643	Oct 21, 2015	Substantially Equivalent	DRTECH Corporation
K152094	GR40CW	Oct 16, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K152279	ViZion DR + Wireless	Sep 10, 2015	Substantially Equivalent	Viztek, LLC
K141488	CAREVIEW 1800R	Sep 08, 2015	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K150929	CareView 1500Cw X-ray Flat Panel Detectors	Aug 04, 2015	Substantially Equivalent	Careray Digital Medical System Co., Ltd.
K151014	Aura DR 43C-AG flat panel detector	Jul 13, 2015	Substantially Equivalent	Abyzr Co., Ltd.
K151465	AeroDR SYSTEM 2	Jun 29, 2015	Substantially Equivalent	Konica Minolta, Inc.
K150766	Carestream DRX-1 System	Jun 24, 2015	Substantially Equivalent	Carestream Health, Inc.
K151221	Kubtec DIGIVIEW 395	Jun 23, 2015	Substantially Equivalent	Kub Technologies, Inc.
K150150	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	Mar 27, 2015	Substantially Equivalent	Rayence Co., Ltd.
K143232	Universal Digital Interface 2W, UDI 2W	Jan 30, 2015	Substantially Equivalent	Meridian Medical Systems, LLC
K143000	RIS500	Jan 23, 2015	Substantially Equivalent	Ray Co., Ltd.
K142475	EVS 4343	Jan 15, 2015	Substantially Equivalent	DRTECH Corporation
K142718	Radlink GPS	Dec 17, 2014	Substantially Equivalent	Radlink, Inc.
K142698	PerkinElmer, XRpad 4343 F MED Flat Panel Detector	Oct 23, 2014	Substantially Equivalent	Perkinelmer, Inc.
K140251	UNIVERSAL DIGITAL INTERFACE 2, UDI 2	Oct 22, 2014	Substantially Equivalent	Meridian Medical Systems, LLC
K142003	FDR D-EVO II FLAT PANEL DETECTOR SYSTEM	Oct 21, 2014	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K142184	DX-D IMAGING PACKAGE	Oct 16, 2014	Substantially Equivalent	Agfa Healthcare N.V.
K141765	FDR D-EVO FLAT PANEL DETECTOR SYSTEM	Oct 03, 2014	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K141743	FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT	Oct 03, 2014	Substantially Equivalent	Radiology Solutions, LLC
K141271	AERODR SYSTEM 2	Sep 26, 2014	Substantially Equivalent	Konica Minolta, Inc.
K141602	DX-D IMAGING PACKAGE	Sep 12, 2014	Substantially Equivalent	Agfa Healthcare N.V.
K141440	DICOMPACS DX-R WITH FLAT PANEL	Aug 29, 2014	Substantially Equivalent	Oehm Und Rehbein GmbH
K141435	OPAL CHIRO, 20/20 P-DR	Aug 27, 2014	Substantially Equivalent	2020 Imaging
K140551	PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR	Aug 01, 2014	Substantially Equivalent	Perkinelmer, Inc.
K141736	PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST	Jul 25, 2014	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K140825	DELWORKS DR SYSTEM	Jul 17, 2014	Substantially Equivalent	Del Medical, Inc.
K141566	SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC	Jul 16, 2014	Substantially Equivalent	Rayence Co., Ltd.
K141563	SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC	Jul 16, 2014	Substantially Equivalent	Rayence Co., Ltd.
K133693	DIGITAL RADIOGRAPHY CXDI-401C WIRELESS	Jul 01, 2014	Substantially Equivalent	Canon, Inc.
K141192	DR 400	Jun 06, 2014	Substantially Equivalent	Agfa Healthcare N.V.
K140235	XGEO GR40CW	May 15, 2014	Substantially Equivalent	Samsung Electronics Co., Ltd.
K140060	DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A	May 13, 2014	Substantially Equivalent	Rayence Co., Ltd.
K140056	DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A	May 13, 2014	Substantially Equivalent	Rayence Co., Ltd.
K140771	PHILIPS ELEVA WORKSPOT	Apr 25, 2014	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K133524	PVMED DDR 2430T	Apr 16, 2014	Substantially Equivalent	Portavision Medical, LLC
K140646	DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G	Apr 11, 2014	Substantially Equivalent	Rayence Co., Ltd.
K133139	VIZION ULTRA	Apr 03, 2014	Substantially Equivalent	Viztek, LLC
K133782	NOVA FA DR SYSTEM	Mar 21, 2014	Substantially Equivalent	Sedecal., Sa.
K133442	BONE SUPPRESSION SOFTWARE	Mar 11, 2014	Substantially Equivalent	Carestream Health, Inc.
K133409	DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA	Feb 21, 2014	Substantially Equivalent	Rayence Co., Ltd.
K132842	FLAATZ 600 SERIES (FLAATZ 600/601)	Feb 21, 2014	Substantially Equivalent	Drtech Corp.
K132921	GALAXY PLUS	Jan 17, 2014	Substantially Equivalent	Medien International Co, Ltd.
K133120	COMPUTED RADIOGRAPHY SCANNER	Jan 15, 2014	Substantially Equivalent	3Disc Americas
K133106	COMPUTED RADIOGRAPHY SCANNER	Jan 15, 2014	Substantially Equivalent	3Disc Americas
K132509	FDR D-EVO FLAT PANEL DETECTOR SYSTEM	Nov 25, 2013	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K131211	DICOMPACS DX-R WITH FLAT PANEL	Nov 05, 2013	Substantially Equivalent	Oehm Und Rehbein GmbH
K131483	PHILIPS PIXIUM 4343RC	Oct 07, 2013	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K131114	DIGITAL FLAT PANEL X-RAY DETECTOR	Sep 17, 2013	Substantially Equivalent	Rayence Co., Ltd.
K131408	CR 12-X DIGITIZER	Aug 29, 2013	Substantially Equivalent	Agfa Healthcare N.V.
K130936	AERODR SYSTEM WITH P-31	Aug 22, 2013	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K131106	DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,	Jul 03, 2013	Substantially Equivalent	Canon, Inc.
K130935	DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA	Jul 02, 2013	Substantially Equivalent	Rayence Co., Ltd.
K131314	DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)	Jun 25, 2013	Substantially Equivalent	Swissray Medical AG
K130567	DR LONG LENGTH IMAGING SOFTWARE	Jun 11, 2013	Substantially Equivalent	Carestream Health, Inc.
K130464	CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR	Jun 07, 2013	Substantially Equivalent	Carestream Health, Inc.
K130377	KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM	May 17, 2013	Substantially Equivalent	Medicatech USA
K130883	SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T	Apr 18, 2013	Substantially Equivalent	Sedecal., Sa.
K123345	DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA	Mar 12, 2013	Substantially Equivalent	Rayence Co., Ltd.
K122736	DX-D IMAGING PACKAGE	Mar 11, 2013	Substantially Equivalent	Agfa Healthcare N.V.
K123740	EOS	Feb 22, 2013	Substantially Equivalent	Eos Imaging
K122865	VIVIX-S WIRELESS	Feb 01, 2013	Substantially Equivalent	Vieworks Co., Ltd.
K122928	DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA	Jan 30, 2013	Substantially Equivalent	Rayence Co., Ltd.
K123644	VIZION + DR	Jan 11, 2013	Substantially Equivalent	Viztek, LLC
K122866	VIVIX-S WITH VXVUE	Jan 11, 2013	Substantially Equivalent	Vieworks Co., Ltd.
K122919	DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA	Jan 01, 2013	Substantially Equivalent	Rayence Co., Ltd.
K123499	AEROPILOT	Dec 20, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K123005	DDRVERSA MOTION	Dec 07, 2012	Substantially Equivalent	Swissray Medical AG
K122495	PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR	Nov 28, 2012	Substantially Equivalent	Perkinelmer, Inc.
K122173	DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC	Oct 19, 2012	Substantially Equivalent	Rayence Co., Ltd.
K122842	RADREX-I, SW V4.00 MODEL DRAD-3000E	Oct 09, 2012	Substantially Equivalent	Toshiba America Medical Systems, In.C
K120629	FDR GO FLEX	Aug 28, 2012	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K122182	DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC	Aug 16, 2012	Substantially Equivalent	Rayence Co., Ltd.
K121095	DX-D IMAGING PACKAGE	Aug 16, 2012	Substantially Equivalent	Agfa Healthcare N.V.
K121948	CR 10-X DIGITIZER	Jul 20, 2012	Substantially Equivalent	Agfa Healthcare N.V.
K121838	LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM	Jul 11, 2012	Substantially Equivalent	Liebel-Flarsheim
K113449	FUSION FLAT PANEL	Jun 14, 2012	Substantially Equivalent	Icrco, Inc.
K112527	UNIVERSAL DIGITAL INTERFACE (UDI) 1717	May 22, 2012	Substantially Equivalent	Meridian Medical Systems, LLC
K121132	EZSENSOR P DIGITAL INTRAORAL SENSOR	May 10, 2012	Substantially Equivalent	Humanray Co,Ltd
K120020	VIVIX-S	May 04, 2012	Substantially Equivalent	Vieworks Co., Ltd.
K113812	ATAL-8	May 03, 2012	Substantially Equivalent	Atlaim
K111824	FLAT PANEL DETECTOR	Apr 23, 2012	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K102327	CLEARVISION DR 7000F	Apr 13, 2012	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K120477	AEROSYNC FOR AERODR SYSTEM	Apr 09, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K120721	EOS	Apr 06, 2012	Substantially Equivalent	Eos Imaging
K120380	SATURN 8000	Mar 09, 2012	Substantially Equivalent	New Medical Co., Ltd.
K120131	REGIUS SIGMA2	Feb 10, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K111305	UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W	Jan 31, 2012	Substantially Equivalent	Meridian Medical Systems, LLC
K113630	DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA	Dec 29, 2011	Substantially Equivalent	Rayence Co., Ltd.
K112751	SDX-4343CS	Nov 23, 2011	Substantially Equivalent	Samsung Mobile Display Co., Ltd.
K113052	INFINIX-CCI	Nov 22, 2011	Substantially Equivalent	Toshiba America Medical Systems, In.C
K112132	KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM	Nov 18, 2011	Substantially Equivalent	Medicatech USA
K112558	DIGITAL FLAT PANEL X-RAY DETECTOR	Nov 10, 2011	Substantially Equivalent	Samsung Mobile Display Co., Ltd.
K112661	VIZION DR	Oct 20, 2011	Substantially Equivalent	Viztek, LLC
K103348	DIGIVIEW 250	Oct 20, 2011	Substantially Equivalent	Kub Technologies, Inc.
K111583	FLAATZ 560	Oct 04, 2011	Substantially Equivalent	Drtech Corp.
K111865	WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE	Sep 30, 2011	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K112309	DIGITAL RADIOGRAPHY	Sep 02, 2011	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K111682	DIGITAL RADIOGRAPHY	Sep 02, 2011	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K111548	WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE	Aug 30, 2011	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K110801	WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM	Aug 02, 2011	Substantially Equivalent	Direct Digital Imaging Technology (Beijing), Inc.
K111312	SANTEVIEW	Jul 13, 2011	Substantially Equivalent	Sehyun Co., Ltd.
K103703	REGUIS SIGMA	Jun 02, 2011	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K102479	ALARA T210 COMPUTED RADIOGRAPHY SYSTEM	Jun 02, 2011	Substantially Equivalent	Alara, Inc.
K111098	INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN	May 27, 2011	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K102619	COMPUTED RADDIOGRAPHY SCANNER	May 13, 2011	Substantially Equivalent	3Disc Americas
K103599	UNIVERSAL DIGITAL INTERFACE (UDI) 1717	Apr 27, 2011	Substantially Equivalent	Meridian Medical Systems, LLC
K110210	SATURN 8000-GS	Apr 20, 2011	Substantially Equivalent	New Medical Co., Ltd.
K103596	WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR	Mar 29, 2011	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K103591	DIGITAL RADIOGRAPHY	Mar 29, 2011	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K102474	FLAATZ 750E	Mar 04, 2011	Substantially Equivalent	Drtech Corp.
K102321	DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP	Feb 11, 2011	Substantially Equivalent	Samsung Mobile Display Co., Ltd.
K100703	STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS	Dec 21, 2010	Substantially Equivalent	Comed Co., Ltd.
K102587	LLX240AB01	Dec 01, 2010	Substantially Equivalent	Samsung Mobile Display Co., Ltd.
K101590	DIGITAL FLAT PANEL X-RAY DETECTOR	Nov 29, 2010	Substantially Equivalent	VATECH Co., Ltd.
K102615	WIRELESS DR IMAGING OPTION-WDR1	Nov 18, 2010	Substantially Equivalent	Ge Medical Systems, LLC
K102012	DIGITAL RADIOGRAPHY	Aug 17, 2010	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K091090	DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717	Aug 09, 2010	Substantially Equivalent	E-Woo Technology
K101289	SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB	Aug 03, 2010	Substantially Equivalent	Air Techniques, Inc.
K100762	FLAT PANEL DETECTOR, MODEL FDR D-EVO	Jul 15, 2010	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K100001	MOBIVISION	Jun 25, 2010	Substantially Equivalent	Almana Medical Imaging
K093790	SIMONDR DRP	Apr 05, 2010	Substantially Equivalent	Simondr, Inc.
K093427	FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR	Jan 21, 2010	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K092669	DX-D IMAGING PACKAGE	Nov 06, 2009	Substantially Equivalent	Agfa Healthcare N.V.
K092717	DIRECT DIGITIZER, REGIUS MODEL 210	Oct 30, 2009	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K090742	DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A	Sep 18, 2009	Substantially Equivalent	Samsung Mobile Display Co., Ltd.
K092238	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS	Aug 11, 2009	Substantially Equivalent	Agfa Healthcare N.V.
K082450	IDR	Jun 30, 2009	Substantially Equivalent	Icrco, Inc.
K091545	DIGITAL RADIOGRAPHY CXDI-60C	Jun 15, 2009	Substantially Equivalent	Canon, Inc.
K091436	DIGITAL RADIOGRAPHY, MODEL CXDI-55C	May 29, 2009	Substantially Equivalent	Canon, Inc.
K091435	DIGITAL RADIOGRAPHY MODEL CXDI-55G	May 29, 2009	Substantially Equivalent	Canon, Inc.
K090672	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS	May 18, 2009	Substantially Equivalent	Agfa Healthcare N.V.
K090062	WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM	May 18, 2009	Substantially Equivalent	Direct Digital Imaging Technology (Beijing), Inc.
K090318	CARESTREAM DRX-1 SYSTEM	Apr 06, 2009	Substantially Equivalent	Carestream Health, Inc.
K090625	WIRELESS PORTABLE DETECTOR FD-W17	Mar 24, 2009	Substantially Equivalent	Philips Medical Systems North America Co.
K090623	DIGITAL RADIOGRAPHY CXDI-40G COMPACT	Mar 24, 2009	Substantially Equivalent	Canon USA, Inc.
K083224	CPI RAD VISION, MODEL VZW2944XX-YY	Mar 24, 2009	Substantially Equivalent	Communications & Power Industries Canada, Inc.
K083645	RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS	Feb 24, 2009	Substantially Equivalent	5 Star Medical, Inc.
K082347	DIGITAL RADIOGRAPHY, FLEXDR C30	Nov 18, 2008	Substantially Equivalent	Konica Minolta Technoproduct Co., Ltd.
K082494	DRAD3000E/RADREX-I	Sep 12, 2008	Substantially Equivalent	Toshiba America Medical Systems, In.C
K081963	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS	Jul 25, 2008	Substantially Equivalent	Agfa Healthcare Corporation
K081648	DIGITAL RADIOGRAPHY CXDI-60G	Jun 24, 2008	Substantially Equivalent	Canon, Inc.
K081624	INFX-8000F (INFINIX CSI AND INFINIX DPI)	Jun 23, 2008	Substantially Equivalent	Toshiba America Medical Systems, In.C
K080589	SATURN 9000-810	Jun 11, 2008	Substantially Equivalent	New Medical Co., Ltd.
K073670	KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260	Jan 25, 2008	Substantially Equivalent	Orex Computed Radiography, Ltd.
K080064	FLAATZ 750	Jan 23, 2008	Substantially Equivalent	Drtech Corp.
K073165	DRAD-3000E, RADREX-I	Nov 16, 2007	Substantially Equivalent	Toshiba America Medical Systems, In.C
K072984	SATURN 9000-550	Nov 14, 2007	Substantially Equivalent	New Medical Co., Ltd.
K073056	DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9	Nov 13, 2007	Substantially Equivalent	Vieworks Co., Ltd.
K072983	SATURN 9000-750	Nov 13, 2007	Substantially Equivalent	New Medical Co., Ltd.
K071682	CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)	Aug 15, 2007	Substantially Equivalent	Alara, Inc.
K063710	SATURN 9000	Jul 16, 2007	Substantially Equivalent	New Medical Co., Ltd.
K071193	VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS	May 30, 2007	Substantially Equivalent	Vidar Systems Corp.
K071181	DIRECT DIGITIZER, REGIUS MODEL 110	May 30, 2007	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K070829	SYNEPIX 4600 DETECTOR	May 09, 2007	Substantially Equivalent	Analogic Corporation
K071162	AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS	May 08, 2007	Substantially Equivalent	Agfa Healthcare Corp.
K070563	VIDAR VISION 2000	Mar 16, 2007	Substantially Equivalent	Vidar Systems Corp.
K070528	PHILIPS ESSENTA DR	Mar 09, 2007	Substantially Equivalent	Philips Medical Systems GmbH, Dmc
K070079	X3C DIGITAL RADIOGRAPHIC DETECTOR	Jan 31, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K063421	DX-SI	Nov 22, 2006	Substantially Equivalent	Agfa Corp.
K063283	DEFINIUM 5000 X-RAY SYSTEM	Nov 17, 2006	Substantially Equivalent	Sedecal., Sa.
K063039	XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM	Nov 02, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K062376	DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI	Oct 27, 2006	Substantially Equivalent	Rf Systems Lab.
K062742	CR 85-X	Oct 13, 2006	Substantially Equivalent	Agfa Corporation
K062586	XPLORER 1600 PLUS	Sep 29, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K062390	CRYSTALVIEW R200	Sep 18, 2006	Substantially Equivalent	Alara, Inc.
K062223	AGFA MODEL CR30-X	Sep 01, 2006	Substantially Equivalent	Agfa Corporation
K062221	CXDI-40EC	Aug 17, 2006	Substantially Equivalent	Canon, Inc.
K061538	ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200	Jun 30, 2006	Substantially Equivalent	Alara, Inc.
K052661	QUIX DIGITAL RADIOGRAPHIC UPGRADE	Jun 07, 2006	Substantially Equivalent	Edge Medical Devices , Ltd.
K061054	AXIOM ARISTOS FX PLUS	May 09, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K060137	KODAK ECLIPSE IMAGE PROCESSING SOFTWARE	Mar 16, 2006	Substantially Equivalent	Eastman Kodak Company
K060433	DIGITAL RADIOGRAPHY CXDI-50C	Mar 10, 2006	Substantially Equivalent	Canon, Inc.
K053634	COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION	Jan 17, 2006	Substantially Equivalent	Agfa Corporation
K053029	NDR+/DIVA-D	Jan 06, 2006	Substantially Equivalent	Nical Spa
K052938	CR-PRO	Nov 17, 2005	Substantially Equivalent	Eradlink, Inc.
K052095	MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190	Nov 03, 2005	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K051998	REGIUS MODEL 170 DIRECT DIGITIZER	Nov 03, 2005	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K051494	MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001	Sep 21, 2005	Substantially Equivalent	Cr Tech, Ltd.
K052136	GR17 DIGITAL DETECTOR	Aug 25, 2005	Substantially Equivalent	Anrad Corp.
K051418	DIRECT DIGITIZER REGIUS MODEL 370	Jul 01, 2005	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K042791	INSTANT-X, MODELS 1713 & 128	Jul 01, 2005	Substantially Equivalent	Ann Arbor Digital Devices
K051483	KODAK DIRECTVIEW DR SYSTEM DETECTOR	Jun 21, 2005	Substantially Equivalent	Eastman Kodak Company
K050925	DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE	Jun 01, 2005	Substantially Equivalent	Shimadzu Corp.
K050718	DDRCOMBI TRAUMA	May 26, 2005	Substantially Equivalent	Swissray International, Inc.
K050987	DIGITAL RADIOGRAPHY MODEL CXDI-40EG	Apr 27, 2005	Substantially Equivalent	Canon, Inc.
K050810	AGFA CR50.0	Apr 21, 2005	Substantially Equivalent	Agfa Corp.
K042602	REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING	Jan 13, 2005	Substantially Equivalent	Ge Medical Systems, LLC
K042386	DIRECT DIGITIZER, REGIUS MODEL 190	Dec 15, 2004	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K042821	DIGITAL DETECTOR, MODEL GR17	Oct 22, 2004	Substantially Equivalent	Anrad Corp.
K042397	SCANX 14	Oct 05, 2004	Substantially Equivalent	Air Techniques, Inc.
K042041	XPLORER 1600	Sep 17, 2004	Substantially Equivalent	Imaging Dynamics Company Limited
K042023	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER	Aug 25, 2004	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K041701	AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM	Jul 22, 2004	Substantially Equivalent	Agfa Corp.
K033561	FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER	Nov 26, 2003	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K032210	ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM	Oct 02, 2003	Substantially Equivalent	Alara, Inc.
K031198	SCANX 10	Jun 20, 2003	Substantially Equivalent	Air Techniques, Inc.
K031633	CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C	Jun 11, 2003	Substantially Equivalent	Canon USA, Inc.
K031447	CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G	May 21, 2003	Substantially Equivalent	Canon, Inc.
K024147	PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM	Feb 12, 2003	Substantially Equivalent	Varian Medical Systems, Inc.
K023750	CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G	Nov 22, 2002	Substantially Equivalent	Canon USA, Inc.
K023586	DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS	Nov 05, 2002	Substantially Equivalent	Canon USA, Inc.
K023061	KONICA DIRECT DIGITIZER REGIUS, MODEL 170	Oct 11, 2002	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K023124	CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT	Oct 04, 2002	Substantially Equivalent	Canon, Inc.
K021829	MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM	Jul 02, 2002	Substantially Equivalent	Eastman Kodak Company
K013897	SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW	May 21, 2002	Substantially Equivalent	Bio-Scan S.A
K020635	KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976	Mar 21, 2002	Substantially Equivalent	Eastman Kodak Company
K013054	KONICA DIRECT DIGITIZER REGIUS MODEL 350	Mar 01, 2002	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K013218	FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II	Dec 20, 2001	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K012750	ADC PEDIATRIC	Nov 14, 2001	Substantially Equivalent	Agfa Corp.
K003238	SOLID STATE X-RAY IMAGING DEVICES	Oct 01, 2001	Substantially Equivalent	Cares Built, Inc.
K013138	ADC COMPACT PLUS	Sep 28, 2001	Substantially Equivalent	Agfa-Gevaert AG
K003438	SMART RAD	Jul 03, 2001	Substantially Equivalent	Cmt Medical Technologies, Ltd.
K001499	PHORMAX EAGLE SCANNER SYSTEM	Dec 27, 2000	Substantially Equivalent	Phormax Corp.
K003256	PCCR DIGITAL IMAGING DEVICE	Nov 08, 2000	Substantially Equivalent	Orex Computed Radiography, Ltd.
K992955	XPLORER 1000	Jun 02, 2000	Substantially Equivalent	Imaging Dynamics Corp.
K993861	FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER	Feb 10, 2000	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K992794	STINGRAY DR, MODEL 1	Nov 09, 1999	Substantially Equivalent	Infimed, Inc.
K992547	CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22	Oct 13, 1999	Substantially Equivalent	Canon USA, Inc.
K990359	KONICA DIRECT DIGITIZER, MODEL DD-341	Aug 17, 1999	Substantially Equivalent	Konica Corp.
K983732	THORAX FD AND MULTIX FD	Apr 21, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K982661	CDR - PAN MODEL 4700	Dec 11, 1998	Substantially Equivalent	Schick Technologies, Inc.
K982795	PHILIPS BUCKY VISION	Nov 24, 1998	Substantially Equivalent	Philips Medical Systems, Inc.
K981556	CANON X-RAY DIGITAL CAMERA CXDI-11	Nov 04, 1998	Substantially Equivalent	Canon USA, Inc.
K973206	STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY	Dec 04, 1997	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.