Product Code: IZL FDA class 2 21 CFR 892.1720

System, X-Ray, Mobile

Radiology

A mobile X-ray system is a portable diagnostic radiographic unit mounted on a wheeled base, enabling bedside imaging of patients who cannot be transported to a fixed radiographic suite, commonly used in intensive care and surgical settings. It is classified as FDA Class 2, reflecting moderate risk and a requirement for 510(k) premarket notification. The product code is IZL, regulated under 21 CFR 892.1720, within the Radiology medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

236

FEI Numbers

Registration Numbers

Unique Applicants

123

Years Active

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Basic Information

Product Code: IZL
Device Class: FDA class 2
Regulation Number: 892.1720
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 236 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253058	Portable DR Imaging System	Jun 18, 2026	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd.
K260085	RAYMO Mobile X-ray System (Model: RAYMO)	May 14, 2026	Substantially Equivalent	DRGEM Corporation
K253185	Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System	Mar 11, 2026	Substantially Equivalent	Carestream Health
K253244	AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)	Feb 23, 2026	Substantially Equivalent	Poskom Co., Ltd.
K250976	Airbile-100	Dec 19, 2025	Substantially Equivalent	Poskom Co., Ltd.
K251710	Mobile X-ray unit (!M1)	Oct 24, 2025	Substantially Equivalent	Solutions For Tomorrow AB
K243864	BONX805	Sep 12, 2025	Substantially Equivalent	Bontech Co., Ltd.
K251443	PROMO	Aug 22, 2025	Substantially Equivalent	DRGEM Corporation
K251223	HnX-P1, HnX-PB	Aug 04, 2025	Substantially Equivalent	H&abyz Co., Ltd.
K250597	REMEX Xcam6	Jul 31, 2025	Substantially Equivalent	Remedi, Inc.
K243473	PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS	Jul 29, 2025	Substantially Equivalent	Prognosys Medical Systems Private Limited
K250750	INNOVISION-P5	Jul 18, 2025	Substantially Equivalent	Dk Medical Systems Co., Ltd.
K244049	Europa (Alternative: AiRTouch) portable X-ray system	May 28, 2025	Substantially Equivalent	Livermoretech, Inc.
K241980	!M1	May 06, 2025	Substantially Equivalent	Solutions For Tomorrow AB
K241996	ULTRA 1040	Apr 18, 2025	Substantially Equivalent	Ecoray Co., Ltd.
K242015	TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)	Dec 16, 2024	Substantially Equivalent	DRGEM Corporation
K241505	DRX-Revolution Mobile X-ray System	Dec 10, 2024	Substantially Equivalent	Carestream Health, Inc.
K240841	Digital Radiography System (ManntiX B, ManntiX K)	Dec 09, 2024	Substantially Equivalent	Shenzhen Browiner Tech Co., Ltd.
K242515	uDR 380i Pro	Oct 10, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K242651	GM85	Oct 01, 2024	Substantially Equivalent	Samsung Electronics Co., Ltd.
K234108	ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)	Sep 20, 2024	Substantially Equivalent	Energy Resources International Co., Ltd.
K240009	iQFlex Pro	Jul 03, 2024	Substantially Equivalent	First Source, Inc.
K240284	Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)	Mar 28, 2024	Substantially Equivalent	Shenzhen Browiner Tech Co., Ltd.
K233678	Radiography 7000 M	Feb 14, 2024	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K232185	SM-IV	Aug 21, 2023	Substantially Equivalent	Sedecal., Sa.
K230581	TOPA12 Portable X-ray Unit	Aug 16, 2023	Substantially Equivalent	Neuf, Inc.
K231577	MOBILETT Impact	Jul 25, 2023	Substantially Equivalent	Siemens Medical Solutions
K222896	AirRay	Dec 20, 2022	Substantially Equivalent	Poskom Co., Ltd.
K222951	SM-V	Nov 21, 2022	Substantially Equivalent	Sedecal., Sa.
K222258	Combined High Frequency X-ray Source	Nov 01, 2022	Substantially Equivalent	Suzhou Powersite Electric Co., Ltd.
K222339	uDR 380i Pro	Sep 30, 2022	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K222353	GM85	Sep 29, 2022	Substantially Equivalent	Samsung Electronics Co., Ltd.
K221417	CLAROX plus (Model: VX-100)	Sep 13, 2022	Substantially Equivalent	Vsi Co., Ltd.
K221803	PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.	Jul 18, 2022	Substantially Equivalent	Sedecal., Sa.
K213405	MINE ALNU (Model: Mine 2.1)	Jul 10, 2022	Substantially Equivalent	Hdt Co., Ltd.
K221081	iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System	Jun 13, 2022	Substantially Equivalent	First Source, Inc.
K220700	Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine	May 04, 2022	Substantially Equivalent	Yian Medical Technology (Haining) Co., Ltd.
K220175	GM85	Apr 21, 2022	Substantially Equivalent	Samsung Electronics Co., Ltd.
K220678	APX-24 Portable X-ray System	Mar 31, 2022	Substantially Equivalent	Aspenstate, Inc.
K213568	DRX-Rise Mobile X-ray System	Mar 23, 2022	Substantially Equivalent	Carestream Health
K212940	Skanmobile, Skanmobile-Dr	Mar 04, 2022	Substantially Equivalent	Skanray Technologies Limited
K213462	EzRay M18 (Model: VMX-P400)	Feb 11, 2022	Substantially Equivalent	VATECH Co., Ltd.
K212654	Micro C Medical Imaging System, M01	Feb 04, 2022	Substantially Equivalent	Oxos Medical, Inc.
K212515	MOVIX DReamy	Nov 03, 2021	Substantially Equivalent	Stephanix
K212291	PHOENIX	Sep 14, 2021	Substantially Equivalent	Sedecal., Sa.
K212134	Diagnostic X-ray System/PLX5200A	Aug 25, 2021	Substantially Equivalent	Nanjing Perlove Medical Equipment Co., Ltd.
K211383	NFLK-2501 Portable X-ray Unit	Aug 13, 2021	Substantially Equivalent	Neuf, Inc.
K212144	Remex KA6	Aug 03, 2021	Substantially Equivalent	Remedi Co., Ltd.
K211473	Micro C Medical Imaging System, M01	Jun 04, 2021	Substantially Equivalent	Oxos Medical, Inc.
K211423	Rover	May 21, 2021	Substantially Equivalent	Micro-X Limited
K210982	AMX Navigate	Apr 28, 2021	Substantially Equivalent	Ge Medical Systems, LLC
K203782	Nanox Cart X-ray System	Apr 01, 2021	Substantially Equivalent	Nano-X Imaging , Ltd.
K210479	IMPACT and X-Ranger	Mar 19, 2021	Substantially Equivalent	Minxray, Inc.
K203667	EzRay M (Model: VMX-P300)	Feb 02, 2021	Substantially Equivalent	VATECH Co., Ltd.
K203658	Micro C Medical Imaging System, M01	Jan 12, 2021	Substantially Equivalent	Oxos Medical, Inc.
K202350	SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System	Jan 06, 2021	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
K202353	SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System	Dec 23, 2020	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
K201488	Rover	Jul 17, 2020	Substantially Equivalent	Micro-X , Ltd.
K200637	SR-8100 Portable X-ray Unit	Jul 09, 2020	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
K201575	CMDR 2C (Multiple Models)	Jul 08, 2020	Substantially Equivalent	Minxray, Inc.
K201340	AQUILA 320 D / AQUILA 320 S	Jun 19, 2020	Substantially Equivalent	Vmi Tecnologias Ltda
K200976	SR-8230, SR-8230S Portable X-ray Unit	Jun 10, 2020	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
K201124	TOPAZ Mobile DR System	May 19, 2020	Substantially Equivalent	DRGEM Corporation
K193535	EZER, Portable X-ray System	May 07, 2020	Substantially Equivalent	Livermoretech, Inc.
K200726	AcuityPDR	Apr 13, 2020	Substantially Equivalent	Radmedix, LLC
K192936	Soltus 500	Nov 15, 2019	Substantially Equivalent	Sedecal., Sa.
K192011	PhoeniX	Sep 25, 2019	Substantially Equivalent	Sedecal., Sa.
K191884	DR 100s	Aug 09, 2019	Substantially Equivalent	Agfa N.V.
K191813	MobileDiagnost wDR 2.2	Aug 02, 2019	Substantially Equivalent	Sedecal., Sa.
K191451	CMDR 2CW (Multiple models)	Jul 03, 2019	Substantially Equivalent	Minxray, Inc.
K191025	DRX-Revolution Mobile X-ray System	May 17, 2019	Substantially Equivalent	Carestream Health, Inc.
K183292	Topaz Mobile DR System	May 15, 2019	Substantially Equivalent	DRGEM Corporation
K182639	MOBILETT Elara Max	Mar 15, 2019	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K183388	JADE Mobile X-Ray	Feb 05, 2019	Substantially Equivalent	DRGEM Corporation
K182207	TR90BH	Dec 14, 2018	Substantially Equivalent	Minxray, Inc.
K182317	AMADEO M-DR mini, AMADEO M-AX mini	Sep 24, 2018	Substantially Equivalent	Oehm Und Rehbein GmbH
K181874	MX40 Mobile Digital X-ray System	Sep 14, 2018	Substantially Equivalent	Huestis Machine Corporation
K182234	Optima XR240amx	Sep 06, 2018	Substantially Equivalent	Ge Medical Systems, LLC
K181626	Digital Diagnostic Mobile X-ray System	Jul 20, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K173924	DRX-Revolution Nano Mobile X-ray System	Feb 05, 2018	Substantially Equivalent	Carestream Health, Inc.
K173299	DRAGON X SPSL4HC, DRAGON X SPSL8HC	Jan 26, 2018	Substantially Equivalent	Sedecal., Sa.
K173602	Optima XR240amx, AutoGrid	Jan 12, 2018	Substantially Equivalent	Ge Medical Systems, LLC
K173018	MDR17 Mobile Direct Radiographic System	Nov 20, 2017	Substantially Equivalent	Del Medical, Inc.
K173187	MobileDiagnost M50	Nov 16, 2017	Substantially Equivalent	Philips India Limited
K170607	!M1	Jul 17, 2017	Substantially Equivalent	Solutions For Tomorrow AB
K170755	DRX-Revolution Nano Mobile X-ray System	Jun 21, 2017	Substantially Equivalent	Carestream Health, Inc.
K171353	CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris	Jun 07, 2017	Substantially Equivalent	Minxray, Inc.
K171119	GM85	May 12, 2017	Substantially Equivalent	Samsung Electronics Co., Ltd.
K170858	FDR AQRO (DR-XD 1000)	Apr 24, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K163063	UC-5000 Mobile X-Ray	Dec 12, 2016	Substantially Equivalent	Source-Ray, Inc.
K162990	Optima XR240amx	Nov 15, 2016	Substantially Equivalent	Ge Medical Systems, LLC
K162278	Digital Diagnostic Mobile X-ray System	Nov 15, 2016	Substantially Equivalent	Samsung Electronics Co., Ltd.
K162687	Paragon 2	Oct 21, 2016	Substantially Equivalent	Meridian Medical Systems, LLC
K161345	RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR	Jul 06, 2016	Substantially Equivalent	Sedecal., Sa.
K153059	HF1202H PowerPlus Portable X-ray Equipment	Feb 02, 2016	Substantially Equivalent	Minxray, Inc.
K143494	ADX6000 Portable X-Ray System; iRayA6	Oct 05, 2015	Substantially Equivalent	Dexcowin Co., Ltd.
K151038	EPX-Series Mobile X-ray System	Jul 24, 2015	Substantially Equivalent	Ecotron Co., Ltd.
K143537	Sirius Starmobile tiara	Mar 06, 2015	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K150097	GM60A-32S & GM60A-40S	Feb 19, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K142492	GM60A-32S, GM60A-40S	Dec 17, 2014	Substantially Equivalent	Samsung Electronics Co., Ltd.
K141539	KUBTEC X250	Oct 29, 2014	Substantially Equivalent	Kub Technologies, Inc.
K142383	Optima XR200amx, Optima XR220amx	Sep 25, 2014	Substantially Equivalent	Ge Medical Systems, LLC
K141895	MOBILEDIAGNOST WDR	Sep 18, 2014	Substantially Equivalent	Sedecal., Sa.
K141885	CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY	Sep 18, 2014	Substantially Equivalent	Minxray, Inc.
K140723	NOMAD MD 75K V HANDHELD X-RAY SYSTEM	Aug 19, 2014	Substantially Equivalent	Aribex, Inc.
K122298	AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR	Mar 28, 2014	Substantially Equivalent	Ajex Meditech., Ltd.
K122697	PORTA 100HF	Oct 05, 2012	Substantially Equivalent	Job Corporation
K121410	DRAGON LW	Aug 02, 2012	Substantially Equivalent	Sedecal., Sa.
K120062	DRX-REVOLUTION MOBILE X-RAY SYSTEM	Apr 13, 2012	Substantially Equivalent	Carestream Health, Inc.
K111912	MOBILETT MIRA	Sep 19, 2011	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K101517	SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY	Aug 05, 2011	Substantially Equivalent	Sedecal., Sa.
K111725	MOBILEDIAGNOST WDR	Jul 19, 2011	Substantially Equivalent	Sedecal., Sa.
K103476	BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX	Jun 16, 2011	Substantially Equivalent	Ge Medical Systems, LLC
K103522	SEDECAL	Jan 26, 2011	Substantially Equivalent	Sedecal., Sa.
K103597	DX-D 100	Jan 03, 2011	Substantially Equivalent	Agfa Healthcare N.V.
K092713	SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM	Jul 16, 2010	Substantially Equivalent	Transamerican Medical Imaging
K100449	MINXRAY MODEL CMDR-2S	Apr 23, 2010	Substantially Equivalent	Minxray, Inc.
K100400	PRESTODR PORTABLE	Apr 22, 2010	Substantially Equivalent	Cmt Medical Technologies, Ltd.
K090655	PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260	Jul 14, 2009	Substantially Equivalent	Source-Ray, Inc.
K090268	SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION	Jun 30, 2009	Substantially Equivalent	Shimadzu Corp.
K090322	EASY MOVING PLUS, SM-XXHF-YY	Mar 17, 2009	Substantially Equivalent	Sedecal., Sa.
K083048	NEORAY DR 2520 DIGITAL IMAGING SYSTEM	Nov 21, 2008	Substantially Equivalent	Portavision Medical, LLC
K082627	MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL	Nov 07, 2008	Substantially Equivalent	Minxray, Inc.
K080701	SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION	May 14, 2008	Substantially Equivalent	Shimadzu Corp.
K080945	FCR GO PORTABLE DIGITAL X-RAY SYSTEM	Apr 18, 2008	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K072392	OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM	Sep 25, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K070634	SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110	Jul 11, 2007	Substantially Equivalent	Soyee Product, Inc.
K071015	OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM	May 10, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K063262	AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS	Dec 26, 2006	Substantially Equivalent	Virtual Imaging
K062472	OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115	Oct 31, 2006	Substantially Equivalent	Source-Ray, Inc.
K061685	PULSERA	Sep 15, 2006	Substantially Equivalent	Philips Medical Systems North America Co.
K060566	MINXRAY, MODELS HFP24 AND HFP40	Apr 05, 2006	Substantially Equivalent	Mikasa X-Ray Co., Ltd.
K052897	GE DEFINIUM AMX 700, MODEL AMX 700	Nov 08, 2005	Substantially Equivalent	General Electric Medical Systems
K052721	MINXRAY, MODEL HF100H+	Oct 27, 2005	Substantially Equivalent	Minxray, Inc.
K052341	AJEX 9015/135H PORTABLE X-RAY	Oct 07, 2005	Substantially Equivalent	Jpi America, Inc.
K052001	MODEL SR-115 PORTABLE X-RAY SYSTEM	Aug 11, 2005	Substantially Equivalent	Source-Ray, Inc.
K043062	MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM	Dec 13, 2004	Substantially Equivalent	Source-Ray, Inc.
K043002	SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR	Nov 18, 2004	Substantially Equivalent	Sedecal., Sa.
K042866	AMX5 AND AMX5D MOBILE X-RAY SYSTEMS	Nov 02, 2004	Substantially Equivalent	Ge Healthcare Technologies
K042368	PRACTIX CONVENIO	Oct 04, 2004	Substantially Equivalent	Philips Medical Systems North America Co.
K042361	DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D	Sep 29, 2004	Substantially Equivalent	Sedecal USA, Inc.
K041922	GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR	Jul 28, 2004	Substantially Equivalent	General Electric Co.
K041763	SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES	Jul 13, 2004	Substantially Equivalent	Shimadzu Corp.
K040046	MINXRAY, MODEL HF120/60H POWERPLUS	Feb 02, 2004	Substantially Equivalent	Minxray, Inc.
K032628	PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF	Feb 02, 2004	Substantially Equivalent	United Radiology Systems, Inc.
K033238	MOBILETTE XP AND MOBILETT XPHYBRID	Nov 14, 2003	Substantially Equivalent	Siemens Medical Systems, Inc.
K032280	SIREMOBIL ISO-C 3D	Sep 10, 2003	Substantially Equivalent	Siemens AG
K030494	SR-130	May 20, 2003	Substantially Equivalent	Source-Ray, Inc.
K022337	3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D	Aug 13, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K021016	AMX-4 PLUS MOBILE X-RAY SYSTEM	Jun 17, 2002	Substantially Equivalent	GE Medical Systems
K020436	PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0	Feb 22, 2002	Substantially Equivalent	Sedecal., Sa.
K012663	EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)	Aug 31, 2001	Substantially Equivalent	Sedecal USA, Inc.
K012379	PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM	Aug 16, 2001	Substantially Equivalent	Trex Enterprises Corp.
K010304	MXR-2000 MOBILE X-RAY UNIT	Feb 12, 2001	Substantially Equivalent	Irom Imaging, Inc.
K002685	CORDLESS COMPACT MOBILE X-RAY SYSTEM	Sep 15, 2000	Substantially Equivalent	Medison Radiology Systems, Inc.
K001517	SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES	Jun 27, 2000	Substantially Equivalent	Shimadzu Corp.
K992229	MXU-125 OR TMX-125	Aug 06, 1999	Substantially Equivalent	Trex Medical Corp.
K981466	XR-910	Jul 14, 1998	Substantially Equivalent	Imaging Sciences Intl., Inc.
K973833	CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL	Dec 30, 1997	Substantially Equivalent	Dynarad Corp.
K973712	MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT	Dec 12, 1997	Substantially Equivalent	Minxray, Inc.
K972365	COMPACT OR COMP-X	Dec 12, 1997	Substantially Equivalent	Eurotec, S.R.L.
K972204	ACU-RAY HF SERIES PORTABLE X-RAY UNIT	Oct 08, 1997	Substantially Equivalent	Sterne Equipment Co., Ltd.
K970234	SEALED LEAD ACID BATTERY PACK	May 02, 1997	Substantially Equivalent	Portable Power Systems, Inc.
K955036	MOBILE X-RAY SYSTEM	Dec 22, 1995	Substantially Equivalent	Shimadzu Corp.
K955095	SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM	Dec 21, 1995	Substantially Equivalent	Sierra Battery, Inc.
K953404	OSTEO-RAY 100	Nov 30, 1995	Substantially Equivalent	Micro Focus Imaging, Inc.
K953292	CP 100/30	Nov 22, 1995	Substantially Equivalent	Micro-Focus Imaging., Inc.
K944442	GENERAL ELECTRIC AMX 110, AMX II AND AMX 3	Mar 14, 1995	Substantially Equivalent	Pro-Tronics, Inc.
K945043	BATTERY PACK #PMX120-18A	Jan 20, 1995	Substantially Equivalent	Portable Power Systems, Inc.
K945707	MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT	Jan 19, 1995	Substantially Equivalent	Minxray, Inc.
K932106	MOBILETT PLUS MOBILE X-RAY SYSTEM	Sep 14, 1994	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K941363	PHANTOM	Jul 20, 1994	Substantially Equivalent	Dynarad Corp.
K931483	REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.	Feb 17, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K932353	HF-110A	Jan 31, 1994	Substantially Equivalent	Dynarad Corp.
K934818	HAND HELD DENTAL X-RAY DEVICE	Jan 24, 1994	Substantially Equivalent	Dept. of the Army
K931279	ACU-RAY	Nov 03, 1993	Substantially Equivalent	Sterne Equipment Co., Ltd.
K930699	M6-M	Aug 09, 1993	Substantially Equivalent	X-Cel X-Ray Corp.
K932355	9150A, 1100F	Aug 03, 1993	Substantially Equivalent	Dynarad Corp.
K932354	9170, 1170	Jul 23, 1993	Substantially Equivalent	Dynarad Corp.
K931200	BATTERY PACKS (VARIOUS MODELS)	Jul 13, 1993	Substantially Equivalent	Access / God Loves You
K930049	INFRARED EXPOSURE HAND SWITCH	Jun 22, 1993	Substantially Equivalent	Mid X-Ray, Inc.
K923359	PORT-XP	Apr 07, 1993	Substantially Equivalent	Mobile Dental Equipment Corp.
K924798	BATTERY PACK	Oct 16, 1992	Substantially Equivalent	Portable Power Systems, Inc.
K921116	PX-100 PORTABLE X-RAY GENERATOR	Oct 05, 1992	Substantially Equivalent	Acoma Medical Imaging, Inc.
K921425	SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R	Aug 27, 1992	Substantially Equivalent	Acoma Medical Imaging, Inc.
K910902	VMX MOBILE X-RAY SYSTEM	Sep 09, 1991	Substantially Equivalent	GE Medical Systems
K912323	THE REMOTE	Sep 06, 1991	Substantially Equivalent	Remote Technologies, Inc.
K911841	MINXRAY P300 X-RAY SYSTEM	Aug 26, 1991	Substantially Equivalent	Minxray, Inc.
K912400	MOBILE X-RAY FLOOR STAND	Aug 09, 1991	Substantially Equivalent	Dntl Corp.
K902984	G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS	Oct 26, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K902610	GENERAL ELECTRIC AMX 3	Jul 02, 1990	Substantially Equivalent	Pro-Tronics, Inc.
K894643	RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT	Dec 14, 1989	Substantially Equivalent	Lorad Medical Systems, Inc.
K894021	MOBILE X-RAY UNIT	Sep 01, 1989	Substantially Equivalent	Ziehm International, Inc.
K893637	MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM	Jul 20, 1989	Substantially Equivalent	Shimadzu Medical Systems
K891143	GENERAL ELECTRIC AMX 110	May 03, 1989	Substantially Equivalent	Pro-Tronics, Inc.
K891142	GENERAL ELECTRIC AMX II	May 01, 1989	Substantially Equivalent	Pro-Tronics, Inc.
K890306	BCM-ARC 105 X-RAY MOBILE UNIT	Apr 17, 1989	Substantially Equivalent	B C Medical , Ltd.
K883092	BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR	Oct 13, 1988	Substantially Equivalent	Bennett X-Ray Corp.
K875106	PB-A LEAD-ACID BATTERY CONVERSION KIT	Feb 22, 1988	Substantially Equivalent	Diagnostic Imaging Specialists Corp.
K874840	BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A	Jan 11, 1988	Substantially Equivalent	Bennett X-Ray Corp.
K873982	GX-MOBILE X-RAY UNIT	Oct 30, 1987	Substantially Equivalent	Gendex Corp.
K862452	MX MOBILE X-RAY SYSTEM	Jul 22, 1986	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K862118	MODEL MBA-130 MOBILE X-RAY SYSTEM	Jun 16, 1986	Substantially Equivalent	Elscint, Inc.
K850678	AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL	Apr 18, 1985	Substantially Equivalent	Fairchild Medical Systems, Inc.
K843192	APR MOBILE	Sep 05, 1984	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K833239	PORTA. X-RAY UNIT FP220 SCM-1-ETC,	Nov 21, 1983	Substantially Equivalent	Showa X-Ray Co., Ltd.
K833226	PMX MOBILE X-RAY SYSTEM	Oct 28, 1983	Substantially Equivalent	Philips Medical Systems, Inc.
K813128	MOBIL-AID AUTOMATIC EXPOSURE CONTROL	Dec 03, 1981	Substantially Equivalent	Advanced Instrument Development, Inc.
K811082	BETA I & BETA II	May 21, 1981	Substantially Equivalent	Porta Ray, Inc.
K810276	ALPHA I AND ALPHA II	Mar 11, 1981	Substantially Equivalent	Porta Ray, Inc.
K803103	TECHNY REX 3000 MOBILE X-RAY UNIT	Jan 22, 1981	Substantially Equivalent	Tecnomed, Inc.
K802047	AMX-III	Oct 23, 1980	Substantially Equivalent	General Electric Co.
K792665	PIXIE	Jan 29, 1980	Substantially Equivalent	Porta Ray, Inc.
K790673	OMNIMEDICAL AUTOMATIC 1001	May 04, 1979	Substantially Equivalent	Omnimedical
K790451	X-RAY UNITS, GX-101, UCIS-510 AND GX-111	Mar 28, 1979	Substantially Equivalent	General X-Ray, Inc.
K790512	PORTABLE X-RAY UNIT	Mar 26, 1979	Substantially Equivalent	General X-Ray, Inc.
K790511	MOBILE X-RAY UNIT	Mar 26, 1979	Substantially Equivalent	General X-Ray, Inc.
K790443	PORTABLE X-RAY UNIT	Mar 26, 1979	Substantially Equivalent	General X-Ray, Inc.
K790393	PORTABLE X-RAY UNIT, MATRIX S GX-101	Mar 26, 1979	Substantially Equivalent	General X-Ray, Inc.
K790392	510 CARBINETTE X-RAY UNIT	Mar 26, 1979	Substantially Equivalent	General X-Ray, Inc.
K782155	GENERAL EQUIPMENT COVER	Jan 17, 1979	Substantially Equivalent	Contour Fabricators, Inc.
K781982	INCLINOMETER, VERMONT	Dec 04, 1978	Substantially Equivalent	Associates IN Radiology, Inc.
K781976	MOBILE X-RAY UNIT	Dec 04, 1978	Substantially Equivalent	General X-Ray, Inc.
K781975	MOBILE CARRIER	Dec 04, 1978	Substantially Equivalent	General X-Ray, Inc.
K781705	MOBIL XR	Oct 24, 1978	Substantially Equivalent	Siemens Corp.
K781676	X-RAY STAND, PORTABLE	Oct 17, 1978	Substantially Equivalent	General X-Ray, Inc.
K781590	PORTABLE X-RAY UNIT	Oct 03, 1978	Substantially Equivalent	General X-Ray, Inc.
K781425	CAP-MOBILE	Sep 11, 1978	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K781276	X-RAY, PORTABLE	Aug 10, 1978	Substantially Equivalent	Air-Shields, Inc.
K781030	X-RAY UNIT, PORTABLE GX-101 AEC	Jul 17, 1978	Substantially Equivalent	General X-Ray, Inc.
K780999	X-RAY FRAME HOLDER	Jun 27, 1978	Substantially Equivalent	Great Eastern Lumber Co., Inc.
K780947	510 BEDSIDE X-RAY SYSTEM	Jun 22, 1978	Substantially Equivalent	Union Carbide Corp.
K780313	HITACHI TECH-MOBLE DHC-121	Mar 14, 1978	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K771571	MOBILE X-RAY SYS. MODEL 43820A	Aug 25, 1977	Substantially Equivalent	Hewlett-Packard Co.
K770903	STERILE CONTINER, X-RAY CASSETTE HOLDER	Jun 29, 1977	Substantially Equivalent	North Shore Orthopaedic Group, S.C.
K760741	PORTABLE X-RAY	Oct 05, 1976	Substantially Equivalent	Minxray, Inc.