Product Code: LMD FDA class 1 21 CFR 892.2020

System, Digital Image Communications, Radiological

Radiology

System, Digital Image Communications, Radiological provides electronic transfer of medical image data between medical devices; it may include a physical communications medium, modems, interfaces, and a communications protocol, and may provide simple image review software such as grayscale window and level, zoom and pan, and geometric measurements, but does not perform advanced image processing or complex quantitative functions. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LMD, regulated under 21 CFR 892.2020, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

142

FEI Numbers

148

Registration Numbers

148

Unique Applicants

102

Years Active

Research product code LMD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LMD
Device Class: FDA class 1
Regulation Number: 892.2020
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 142 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K994329	IIVS INTEGRATED IMAGE VIEWING STATION	May 26, 2000	Substantially Equivalent	Terarecon,Inc.
K992698	STENTOR, PAGEVIEW	Oct 25, 1999	Substantially Equivalent	Stentor, Inc.
K992426	RAYPAX WEB CLINICAL SYSTEM	Oct 13, 1999	Substantially Equivalent	Samsung Sds Co., Ltd.
K992352	ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0	Sep 29, 1999	Substantially Equivalent	Inteleradiology, Inc.
K991537	SAMSUNG RAYPAX SYSTEM	Jul 06, 1999	Substantially Equivalent	Samsung Sds Co., Ltd.
K984000	STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM	Jan 12, 1999	Substantially Equivalent	Surgical Navigation Technologies, Inc.
K974707	IMAGEQUEST	Jul 31, 1998	Substantially Equivalent	Visual Med, Inc.
K981053	KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW	Jun 18, 1998	Substantially Equivalent	Eastman Kodak Company
K980918	JPACS	Jun 03, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K974882	DOWNSCAN LT	May 22, 1998	Substantially Equivalent	Merlin Engineering Works, Inc.
K980684	VR NETSERVE	May 06, 1998	Substantially Equivalent	I.S.G. Technologies, Inc.
K980541	BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY	Apr 09, 1998	Substantially Equivalent	Barco NV Display Systems
K980241	NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE	Mar 17, 1998	Substantially Equivalent	Netco Communications Corp.
K980220	IISYS PACS SYSTEM	Feb 13, 1998	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.
K974130	VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE	Jan 29, 1998	Substantially Equivalent	Dejarnette Research Systems
K974255	CD-R STATION AND VRS-2000	Jan 27, 1998	Substantially Equivalent	Electromed Intl., Ltd.
K974107	KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)	Jan 21, 1998	Substantially Equivalent	Eastman Kodak Company
K974102	MILTRA IMAGING INC., IMAGE VAULT	Jan 20, 1998	Substantially Equivalent	Mitra Imaging, Inc.
K973805	IMAGEACCESS SYSTEM	Jan 02, 1998	Substantially Equivalent	Storcomm, Inc.
K972701	BARCO MWD 321 MEDICAL WORKSTATION DISPLAY	Jan 02, 1998	Substantially Equivalent	Barco NV Display Systems
K973959	OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE	Dec 22, 1997	Substantially Equivalent	Olicon Imaging Systems, Inc.
K973793	OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE	Dec 17, 1997	Substantially Equivalent	Olicon Imaging Systems, Inc.
K973421	IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}	Dec 05, 1997	Substantially Equivalent	Dejarnette Research Systems
K972925	ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC	Dec 05, 1997	Substantially Equivalent	Access Radiology Corp.
K973239	DICOM 3.0 SOFTWARE VERSION 2.0	Nov 26, 1997	Substantially Equivalent	Adac Laboratories
K973303	IMATION MODEL 9410 NETWORK INTERFACE	Nov 25, 1997	Substantially Equivalent	Imation Corp.
K973131	SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)	Nov 12, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K973090	MEDSTATION	Oct 28, 1997	Substantially Equivalent	Program S.R.L.
K972366	IMNET DICOM NETWORK AGENT	Sep 23, 1997	Substantially Equivalent	Imnet Systems, Inc.
K972191	DIGITIZER DIRECTOR (HSC025-01)	Sep 08, 1997	Substantially Equivalent	Howtek, Inc.
K971347	MEDISURF	Jul 03, 1997	Substantially Equivalent	International Regulatory Consultants
K971154	MULTIPICS(ME-977)	Jun 25, 1997	Substantially Equivalent	Merlin Engineering Works, Inc.
K971153	SPLITSCREEN (ME-975)	Jun 25, 1997	Substantially Equivalent	Merlin Engineering Works, Inc.
K970628	GE ADVANTAGE DIGITIZER WORKSTATION	May 12, 1997	Substantially Equivalent	Ge Medical Systems, Inc.
K970652	MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE	May 02, 1997	Substantially Equivalent	Mitra Imaging, Inc.
K970641	RIS SCANVIEW SYSTEM (RSVS)	May 02, 1997	Substantially Equivalent	Radiology Information Systems, Inc.
K970174	FREEPIX/PIXPACS DICOM/HTTP GATEWAY	May 01, 1997	Substantially Equivalent	Pixelinks, Inc.
K970293	FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666	Mar 21, 1997	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K970064	AMICAS WEB/INTRANET IMAGE SERVER	Mar 17, 1997	Substantially Equivalent	Autocyt Group, Inc.
K965161	SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)	Mar 12, 1997	Substantially Equivalent	Sectra-Imtec AB
K964250	LINX NETWORKING SYSTEM	Dec 18, 1996	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.
K963861	LASERSHARE PRINT SPOOLER AND/OR SOFTWARE	Dec 18, 1996	Substantially Equivalent	Dejarnette Research Systems
K963628	IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE	Nov 07, 1996	Substantially Equivalent	Dejarnette Research Systems
K963594	IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)	Nov 07, 1996	Substantially Equivalent	Dejarnette Research Systems
K963592	IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000	Nov 07, 1996	Substantially Equivalent	Dejarnette Research Systems
K962225	VIEWSEND MEDICAL MODEL 1200	Oct 25, 1996	Substantially Equivalent	Klt Telecom, Inc.
K961023	AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)	Sep 09, 1996	Substantially Equivalent	Accuimage, Inc.
K962699	RADWORKS MEDICAL IMAGING SOFTWARE	Aug 19, 1996	Substantially Equivalent	Applicare Medical Imaging, B.V.
K961689	INFINET	Jul 31, 1996	Substantially Equivalent	Infimed, Inc.
K961753	SHARED VISION(PART NUMBER SV 0015)	Jul 25, 1996	Substantially Equivalent	Imagelabs, Inc.
K960911	NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE	May 29, 1996	Substantially Equivalent	Scimage, Inc.
K960382	KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER	Apr 17, 1996	Substantially Equivalent	Eastman Kodak Company
K954567	RTI MEDICAL	Apr 12, 1996	Substantially Equivalent	Radiology Telenetwork Intl.
K960809	PHILIPS SITE VIEW WORKSTATION	Apr 07, 1996	Substantially Equivalent	Philips Medical Systems North America, Inc.
K954691	ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM	Mar 29, 1996	Substantially Equivalent	Access Radiology Corp.
K954172	X-RAY VISIONS	Mar 15, 1996	Substantially Equivalent	Image Visions, LLC
K955708	COMPUMED DICON CLIENT	Mar 01, 1996	Substantially Equivalent	Compumed, Inc.
K954071	IDXVIEW	Feb 27, 1996	Substantially Equivalent	Idx Systems Corp.
K954479	DICOMVIEW	Feb 21, 1996	Substantially Equivalent	Heartlab, Inc.
K955000	REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE	Jan 26, 1996	Substantially Equivalent	Cerner Corp.
K950513	ARCHIVEMANAGER	Nov 13, 1995	Substantially Equivalent	Cemax, Inc.
K954008	REDI-VU SYSTEMS (SEND & RECEIVE)	Oct 27, 1995	Substantially Equivalent	Jd Technical Services, Inc.
K953552	SIENET SPI SPOOLER	Oct 24, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K953371	LUMISYS DICOM TOOKLIT	Oct 18, 1995	Substantially Equivalent	Lumisys, Inc.
K953514	COURIER II	Oct 07, 1995	Substantially Equivalent	Gammex, Inc.
K953398	UNISCAN	Oct 06, 1995	Substantially Equivalent	Merlin Engineering Works, Inc.
K953080	DIGITAL IMAGING SYSTEM INTERFACE	Sep 28, 1995	Substantially Equivalent	Camtronics, Ltd.
K953163	QUICK READ 2000 (QR2000)	Sep 22, 1995	Substantially Equivalent	Quicksilver Systems, Inc.
K952914	STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM	Sep 18, 1995	Substantially Equivalent	Star Technologies, Inc.
K952533	SIENET DICOM GATEWAY	Aug 23, 1995	Substantially Equivalent	Siemens AG
K951175	MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)	Jun 30, 1995	Substantially Equivalent	Sirius Corp.
K950413	MEDIPACS	Jun 30, 1995	Substantially Equivalent	Nexsys Electronics
K952484	MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A	Jun 23, 1995	Substantially Equivalent	Toshiba America Medical Systems, In.C
K943994	PACS EQUIPMENT	May 12, 1995	Substantially Equivalent	Rstar Image Management System
K950431	LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM	May 04, 1995	Substantially Equivalent	Open Mri, Inc.
K950699	PREVIEW TELEIMAGING SYSTEM	May 03, 1995	Substantially Equivalent	Regulatory Management Services
K950343	HYPERPACS PACS AND TELERAFIOLOGY SYSTEM	Apr 12, 1995	Substantially Equivalent	Rogan Imaging Corp.
K944322	AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM	Feb 24, 1995	Substantially Equivalent	At&T Image Solutions
K925964	IMAGE TRANSPORT SERIES III	Feb 03, 1995	Substantially Equivalent	Dataview Imaging Intl., Inc.
K940859	PACSPRO I	Feb 01, 1995	Substantially Equivalent	Advanced Video Products, Inc.
K944771	INTRASCAN II	Jan 26, 1995	Substantially Equivalent	Markcare Medical Systems, Inc.
K944130	RIT 531 TELERADIOLOGY/ PAC SYSTEM	Dec 23, 1994	Substantially Equivalent	Radiological Imaging Technology, Inc.
K941224	LENZAR REMOTE ACQUISITION SYSTEM	Dec 09, 1994	Substantially Equivalent	Lenzar Electrooptics, Inc.
K942861	MEDVISION ENVIROMENT/MEDVISION 2.0	Dec 07, 1994	Substantially Equivalent	Evergreen Technologies, Inc.
K943383	IMAGING WORKBENCH	Nov 22, 1994	Substantially Equivalent	Brit Systems, Inc.
K943158	AD/V IMAGEPLEX(TM)	Nov 22, 1994	Substantially Equivalent	Adaptive Video, Inc.
K942917	ULTRAPRO WORKSTATION	Nov 14, 1994	Substantially Equivalent	Ramsoft, Inc.
K940423	NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE	Jul 29, 1994	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K941203	MEDICAL IMAGING WORKSTATION II (MIW II)	Jun 27, 1994	Substantially Equivalent	Cemco, Inc.
K941086	PACSPRO II	Jun 27, 1994	Substantially Equivalent	Advanced Video Products, Inc.
K940408	REMOTE CONSOLE	Jun 08, 1994	Substantially Equivalent	Robinson Engineering Teleradiology System
K936153	3M 1156 MULTI-INPUT SYSTEM	May 23, 1994	Substantially Equivalent	3M Information,Imaging and Electronic Sector
K936116	KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS	Apr 29, 1994	Substantially Equivalent	Eastman Kodak Company
K935103	VISIONLINK ACR-NEMA CONVERSION UTILITIES	Feb 09, 1994	Substantially Equivalent	Evergreen Technologies, Inc.
K934386	IMPAX 5000	Jan 05, 1994	Substantially Equivalent	Heraeus Kulzer, Inc.
K930500	MAXIVIEW DIAGNOSTIC WORKSTATION	Dec 29, 1993	Substantially Equivalent	Dimensional Medicine, Inc.
K926315	PRACTICE PARTNER	Dec 13, 1993	Substantially Equivalent	Rs Imaging
K931186	PHOTOPHONE MULTIVIEW	Nov 22, 1993	Substantially Equivalent	Image Data Corp.
K931795	TELERAD STAT	Nov 19, 1993	Substantially Equivalent	Magnetic Research, Inc.
K933409	IMPAX 1000	Nov 03, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K933103	DIGITAL IMAGE COMMUNICATIONS SYSTEM	Oct 05, 1993	Substantially Equivalent	Analogic Corp.
K933098	MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL	Sep 20, 1993	Substantially Equivalent	Siemens Medical Solutions Health Services Corporat
K925864	COURIER PC	Sep 20, 1993	Substantially Equivalent	Shoreline Business Consulting
K931292	MULTIVIEW FOR WINDOWS	Jul 29, 1993	Substantially Equivalent	Image Data Corp.
K931551	KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)	Jun 29, 1993	Substantially Equivalent	Eastman Kodak Company
K926098	DIGIRAY	Jun 25, 1993	Substantially Equivalent	Telescan Corp.
K931060	STATVIEW	May 20, 1993	Substantially Equivalent	Image Data Corp.
K925050	PC TELERADIOLOGY(TM)	May 03, 1993	Substantially Equivalent	Arizona State Radiology
K930350	RADMAN IMAGE MANAGMENT SYSTEM	Apr 27, 1993	Substantially Equivalent	Infocure Systems, Inc.
K930997	DOMINATOR RADIOLOGY SYSTEM	Apr 07, 1993	Substantially Equivalent	Dominator Radiology Systems, Inc.
K921185	TELEMEDIC TELERADIOLOGY SYSTEM	Mar 29, 1993	Substantially Equivalent	Meditron Corp.
K925994	RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)	Mar 18, 1993	Substantially Equivalent	Rstar, Inc.
K925929	RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)	Mar 15, 1993	Substantially Equivalent	Rstar, Inc.
K924178	MEDVISION(TM) IMAGING SOFTWARE	Feb 02, 1993	Substantially Equivalent	Evergreen Technologies, Inc.
K925284	IMAGESSSHARE 910	Jan 21, 1993	Substantially Equivalent	Dejarnette Research Systems
K922164	RAYTEL DIGITAL IMAGING SYSTEMS	Jan 21, 1993	Substantially Equivalent	Olicon Imaging Systems, Inc.
K925097	VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)	Jan 15, 1993	Substantially Equivalent	Vortech Data, Inc.
K924229	VG-A MIG	Nov 27, 1992	Substantially Equivalent	Vortech Data, Inc.
K923582	SIENET CAMERA SERVER	Oct 14, 1992	Substantially Equivalent	Siemens Gammasonics, Inc.
K921877	AD/V SPOOLER	Jul 01, 1992	Substantially Equivalent	Adaptive Video, Inc.
K921527	STATVIEW	Jun 24, 1992	Substantially Equivalent	Image Data Corp.
K920268	3M DIGITAL DISK INTERFACE UNIT	May 27, 1992	Substantially Equivalent	3M Company
K921278	M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION	May 18, 1992	Substantially Equivalent	Metecon, Inc.
K920310	SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE	Mar 30, 1992	Substantially Equivalent	Siemens Gammasonics, Inc.
K914444	XPR PRINTER REDUNDANCY	Feb 27, 1992	Substantially Equivalent	Vortech Data, Inc.
K914191	XLP NETWORK PRINTING	Feb 18, 1992	Substantially Equivalent	Vortech Data, Inc.
K911773	PHILIPS TELESCAN	Jun 28, 1991	Substantially Equivalent	Philips Medical Systems, Inc.
K911405	KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T	Apr 23, 1991	Substantially Equivalent	Eastman Kodak Company
K905199	PACSNET RESEARCH TOOLKIT	Jan 14, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K900935	DU PONT LINX LASER IMAGER W/THE LINX NETWORKING	May 15, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K896095	IMAGES-ON-CALL TELERADIOLOGY SYSTEM	Feb 16, 1990	Substantially Equivalent	Devices & Services Co.
K900227	MVP (MULTI-VENDOR PROTOCOL CONVERTOR)	Feb 12, 1990	Substantially Equivalent	Merge Technologies, Inc.
K895209	FILMFAX	Oct 27, 1989	Substantially Equivalent	Discovery Systems, Inc.
K891192	MEDI-TRACE THERMAL VIDEO FILM PAPER	Apr 06, 1989	Substantially Equivalent	Graphic Controls Corp.
K884434	VORTECH'S MEDICAL IMAGING GATEWAY	Jan 19, 1989	Substantially Equivalent	Vortech Data, Inc.
K882754	REPORT AND IMAGE MANAGEMENT SYSTEM	Oct 21, 1988	Substantially Equivalent	Medical Image Processing Specialists, Inc.
K873121	GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)	Aug 23, 1988	Substantially Equivalent	General Electric Co.
K871984	KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE	Aug 12, 1987	Substantially Equivalent	Eastman Kodak Company
K862158	AVP TELEIMAGING SYSTEM	Nov 28, 1986	Substantially Equivalent	Advanced Video Products, Inc.
K862744	TELERADIOGRAPHY SYSTEM	Nov 26, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K862715	COMMVIEW SYSTEM	Oct 16, 1986	Substantially Equivalent	A T & T Technologies, Inc.
K850417	INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK	Oct 16, 1985	Substantially Equivalent	Impact Systems Corp.