Atlas FDA

LMD

142 FDA 510(k) clearances · Product code

90 daysmedian time to decision
221 days90th percentile
142clearances measured

FDA profile

Official device name
System, Digital Image Communications, Radiological
Device class
Class I (low risk)
Regulation
21 CFR 892.2020
Medical specialty
Radiology
FDA 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.
Adverse events (MAUDE)
2006: 2 · 2009: 3 · 2010: 9 · 2014: 12 · 2015: 9 · 2026: 43
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IIVS INTEGRATED IMAGE VIEWING STATION (K994329)Terarecon,Inc.2000-05-26
STENTOR, PAGEVIEW (K992698)Stentor, Inc.1999-10-25
RAYPAX WEB CLINICAL SYSTEM (K992426)Samsung Sds Co., Ltd.1999-10-13
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (K992352)Inteleradiology, Inc.1999-09-29
SAMSUNG RAYPAX SYSTEM (K991537)Samsung Sds Co., Ltd.1999-07-06
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (K984000)Surgical Navigation Technologies, Inc.1999-01-12
IMAGEQUEST (K974707)Visual Med, Inc.1998-07-31
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053)Eastman Kodak Company1998-06-18
JPACS (K980918)Philips Medical Systems (Cleveland), Inc.1998-06-03
DOWNSCAN LT (K974882)Merlin Engineering Works, Inc.1998-05-22
VR NETSERVE (K980684)I.S.G. Technologies, Inc.1998-05-06
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541)Barco NV Display Systems1998-04-09
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE (K980241)Netco Communications Corp.1998-03-17
IISYS PACS SYSTEM (K980220)Sterling Diagnostic Imaging, Inc.1998-02-13
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE (K974130)Dejarnette Research Systems1998-01-29
CD-R STATION AND VRS-2000 (K974255)Electromed Intl., Ltd.1998-01-27
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) (K974107)Eastman Kodak Company1998-01-21
MILTRA IMAGING INC., IMAGE VAULT (K974102)Mitra Imaging, Inc.1998-01-20
IMAGEACCESS SYSTEM (K973805)Storcomm, Inc.1998-01-02
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY (K972701)Barco NV Display Systems1998-01-02
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE (K973959)Olicon Imaging Systems, Inc.1997-12-22
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE (K973793)Olicon Imaging Systems, Inc.1997-12-17
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC (K972925)Access Radiology Corp.1997-12-05
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} (K973421)Dejarnette Research Systems1997-12-05
DICOM 3.0 SOFTWARE VERSION 2.0 (K973239)Adac Laboratories1997-11-26
IMATION MODEL 9410 NETWORK INTERFACE (K973303)Imation Corp.1997-11-25
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) (K973131)Siemens Medical Solutions USA, Inc.1997-11-12
MEDSTATION (K973090)Program S.R.L.1997-10-28
IMNET DICOM NETWORK AGENT (K972366)Imnet Systems, Inc.1997-09-23
DIGITIZER DIRECTOR (HSC025-01) (K972191)Howtek, Inc.1997-09-08
MEDISURF (K971347)International Regulatory Consultants1997-07-03
MULTIPICS(ME-977) (K971154)Merlin Engineering Works, Inc.1997-06-25
SPLITSCREEN (ME-975) (K971153)Merlin Engineering Works, Inc.1997-06-25
GE ADVANTAGE DIGITIZER WORKSTATION (K970628)Ge Medical Systems, Inc.1997-05-12
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE (K970652)Mitra Imaging, Inc.1997-05-02
RIS SCANVIEW SYSTEM (RSVS) (K970641)Radiology Information Systems, Inc.1997-05-02
FREEPIX/PIXPACS DICOM/HTTP GATEWAY (K970174)Pixelinks, Inc.1997-05-01
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 (K970293)Fujifilm Medical System U.S.A., Inc.1997-03-21
AMICAS WEB/INTRANET IMAGE SERVER (K970064)Autocyt Group, Inc.1997-03-17
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (K965161)Sectra-Imtec AB1997-03-12
LINX NETWORKING SYSTEM (K964250)Sterling Diagnostic Imaging, Inc.1996-12-18
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE (K963861)Dejarnette Research Systems1996-12-18
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 (K963592)Dejarnette Research Systems1996-11-07
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) (K963594)Dejarnette Research Systems1996-11-07
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE (K963628)Dejarnette Research Systems1996-11-07
VIEWSEND MEDICAL MODEL 1200 (K962225)Klt Telecom, Inc.1996-10-25
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) (K961023)Accuimage, Inc.1996-09-09
RADWORKS MEDICAL IMAGING SOFTWARE (K962699)Applicare Medical Imaging, B.V.1996-08-19
INFINET (K961689)Infimed, Inc.1996-07-31
SHARED VISION(PART NUMBER SV 0015) (K961753)Imagelabs, Inc.1996-07-25
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE (K960911)Scimage, Inc.1996-05-29
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER (K960382)Eastman Kodak Company1996-04-17
RTI MEDICAL (K954567)Radiology Telenetwork Intl.1996-04-12
PHILIPS SITE VIEW WORKSTATION (K960809)Philips Medical Systems North America, Inc.1996-04-07
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM (K954691)Access Radiology Corp.1996-03-29
X-RAY VISIONS (K954172)Image Visions, LLC1996-03-15
COMPUMED DICON CLIENT (K955708)Compumed, Inc.1996-03-01
IDXVIEW (K954071)Idx Systems Corp.1996-02-27
DICOMVIEW (K954479)Heartlab, Inc.1996-02-21
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE (K955000)Cerner Corp.1996-01-26
ARCHIVEMANAGER (K950513)Cemax, Inc.1995-11-13
REDI-VU SYSTEMS (SEND & RECEIVE) (K954008)Jd Technical Services, Inc.1995-10-27
SIENET SPI SPOOLER (K953552)Siemens Medical Solutions USA, Inc.1995-10-24
LUMISYS DICOM TOOKLIT (K953371)Lumisys, Inc.1995-10-18
COURIER II (K953514)Gammex, Inc.1995-10-07
UNISCAN (K953398)Merlin Engineering Works, Inc.1995-10-06
DIGITAL IMAGING SYSTEM INTERFACE (K953080)Camtronics, Ltd.1995-09-28
QUICK READ 2000 (QR2000) (K953163)Quicksilver Systems, Inc.1995-09-22
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM (K952914)Star Technologies, Inc.1995-09-18
SIENET DICOM GATEWAY (K952533)Siemens AG1995-08-23
MEDIPACS (K950413)Nexsys Electronics1995-06-30
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS) (K951175)Sirius Corp.1995-06-30
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A (K952484)Toshiba America Medical Systems, In.C1995-06-23
PACS EQUIPMENT (K943994)Rstar Image Management System1995-05-12
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM (K950431)Open Mri, Inc.1995-05-04
PREVIEW TELEIMAGING SYSTEM (K950699)Regulatory Management Services1995-05-03
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM (K950343)Rogan Imaging Corp.1995-04-12
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM (K944322)At&T Image Solutions1995-02-24
IMAGE TRANSPORT SERIES III (K925964)Dataview Imaging Intl., Inc.1995-02-03
PACSPRO I (K940859)Advanced Video Products, Inc.1995-02-01
INTRASCAN II (K944771)Markcare Medical Systems, Inc.1995-01-26
RIT 531 TELERADIOLOGY/ PAC SYSTEM (K944130)Radiological Imaging Technology, Inc.1994-12-23
LENZAR REMOTE ACQUISITION SYSTEM (K941224)Lenzar Electrooptics, Inc.1994-12-09
MEDVISION ENVIROMENT/MEDVISION 2.0 (K942861)Evergreen Technologies, Inc.1994-12-07
IMAGING WORKBENCH (K943383)Brit Systems, Inc.1994-11-22
AD/V IMAGEPLEX(TM) (K943158)Adaptive Video, Inc.1994-11-22
ULTRAPRO WORKSTATION (K942917)Ramsoft, Inc.1994-11-14
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (K940423)Advanced Technology Laboratories, Inc.1994-07-29
MEDICAL IMAGING WORKSTATION II (MIW II) (K941203)Cemco, Inc.1994-06-27
PACSPRO II (K941086)Advanced Video Products, Inc.1994-06-27
REMOTE CONSOLE (K940408)Robinson Engineering Teleradiology System1994-06-08
3M 1156 MULTI-INPUT SYSTEM (K936153)3M Information,Imaging and Electronic Sector1994-05-23
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS (K936116)Eastman Kodak Company1994-04-29
VISIONLINK ACR-NEMA CONVERSION UTILITIES (K935103)Evergreen Technologies, Inc.1994-02-09
IMPAX 5000 (K934386)Heraeus Kulzer, Inc.1994-01-05
MAXIVIEW DIAGNOSTIC WORKSTATION (K930500)Dimensional Medicine, Inc.1993-12-29
PRACTICE PARTNER (K926315)Rs Imaging1993-12-13
PHOTOPHONE MULTIVIEW (K931186)Image Data Corp.1993-11-22
TELERAD STAT (K931795)Magnetic Research, Inc.1993-11-19
IMPAX 1000 (K933409)Heraeus Kulzer, Inc.1993-11-03
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