FDA Product Code
FDA Product Code LMD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2020
510(k) Clearances — 142 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | Terarecon,Inc. | 2000-05-26 | Traditional | PDF ↗ |
| K992698 | STENTOR, PAGEVIEW | Stentor, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K992426 | RAYPAX WEB CLINICAL SYSTEM | Samsung Sds Co., Ltd. | 1999-10-13 | Traditional | PDF ↗ |
| K992352 | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | Inteleradiology, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K991537 | SAMSUNG RAYPAX SYSTEM | Samsung Sds Co., Ltd. | 1999-07-06 | Traditional | PDF ↗ |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-12 | Traditional | PDF ↗ |
| K974707 | IMAGEQUEST | Visual Med, Inc. | 1998-07-31 | Traditional | PDF ↗ |
| K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW | Eastman Kodak Company | 1998-06-18 | Traditional | PDF ↗ |
| K980918 | JPACS | Philips Medical Systems (Cleveland), Inc. | 1998-06-03 | Traditional | PDF ↗ |
| K974882 | DOWNSCAN LT | Merlin Engineering Works, Inc. | 1998-05-22 | Traditional | PDF ↗ |
| K980684 | VR NETSERVE | I.S.G. Technologies, Inc. | 1998-05-06 | Traditional | PDF ↗ |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | Barco NV Display Systems | 1998-04-09 | Traditional | PDF ↗ |
| K980241 | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE | Netco Communications Corp. | 1998-03-17 | Traditional | PDF ↗ |
| K980220 | IISYS PACS SYSTEM | Sterling Diagnostic Imaging, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | Dejarnette Research Systems | 1998-01-29 | Traditional | PDF ↗ |
| K974255 | CD-R STATION AND VRS-2000 | Electromed Intl., Ltd. | 1998-01-27 | Traditional | PDF ↗ |
| K974107 | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) | Eastman Kodak Company | 1998-01-21 | Traditional | PDF ↗ |
| K974102 | MILTRA IMAGING INC., IMAGE VAULT | Mitra Imaging, Inc. | 1998-01-20 | Traditional | PDF ↗ |
| K973805 | IMAGEACCESS SYSTEM | Storcomm, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | Barco NV Display Systems | 1998-01-02 | Traditional | PDF ↗ |
| K973959 | OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE | Olicon Imaging Systems, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K973793 | OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE | Olicon Imaging Systems, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K973421 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} | Dejarnette Research Systems | 1997-12-05 | Traditional | PDF ↗ |
| K972925 | ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC | Access Radiology Corp. | 1997-12-05 | Traditional | PDF ↗ |
| K973239 | DICOM 3.0 SOFTWARE VERSION 2.0 | Adac Laboratories | 1997-11-26 | Traditional | PDF ↗ |
| K973303 | IMATION MODEL 9410 NETWORK INTERFACE | Imation Corp. | 1997-11-25 | Traditional | PDF ↗ |
| K973131 | SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) | Siemens Medical Solutions USA, Inc. | 1997-11-12 | Traditional | PDF ↗ |
| K973090 | MEDSTATION | Program S.R.L. | 1997-10-28 | Traditional | PDF ↗ |
| K972366 | IMNET DICOM NETWORK AGENT | Imnet Systems, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K972191 | DIGITIZER DIRECTOR (HSC025-01) | Howtek, Inc. | 1997-09-08 | Traditional | PDF ↗ |
| K971347 | MEDISURF | International Regulatory Consultants | 1997-07-03 | Traditional | PDF ↗ |
| K971153 | SPLITSCREEN (ME-975) | Merlin Engineering Works, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K971154 | MULTIPICS(ME-977) | Merlin Engineering Works, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970628 | GE ADVANTAGE DIGITIZER WORKSTATION | Ge Medical Systems, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K970641 | RIS SCANVIEW SYSTEM (RSVS) | Radiology Information Systems, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K970652 | MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE | Mitra Imaging, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K970174 | FREEPIX/PIXPACS DICOM/HTTP GATEWAY | Pixelinks, Inc. | 1997-05-01 | Traditional | PDF ↗ |
| K970293 | FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 | Fujifilm Medical System U.S.A., Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K970064 | AMICAS WEB/INTRANET IMAGE SERVER | Autocyt Group, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K965161 | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) | Sectra-Imtec AB | 1997-03-12 | Traditional | PDF ↗ |
| K964250 | LINX NETWORKING SYSTEM | Sterling Diagnostic Imaging, Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K963861 | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE | Dejarnette Research Systems | 1996-12-18 | Traditional | PDF ↗ |
| K963594 | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) | Dejarnette Research Systems | 1996-11-07 | Traditional | PDF ↗ |
| K963592 | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 | Dejarnette Research Systems | 1996-11-07 | Traditional | PDF ↗ |
| K963628 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE | Dejarnette Research Systems | 1996-11-07 | Traditional | PDF ↗ |
| K962225 | VIEWSEND MEDICAL MODEL 1200 | Klt Telecom, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K961023 | AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) | Accuimage, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K962699 | RADWORKS MEDICAL IMAGING SOFTWARE | Applicare Medical Imaging, B.V. | 1996-08-19 | Traditional | PDF ↗ |
| K961689 | INFINET | Infimed, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K961753 | SHARED VISION(PART NUMBER SV 0015) | Imagelabs, Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K960911 | NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE | Scimage, Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K960382 | KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER | Eastman Kodak Company | 1996-04-17 | Traditional | PDF ↗ |
| K954567 | RTI MEDICAL | Radiology Telenetwork Intl. | 1996-04-12 | Traditional | PDF ↗ |
| K960809 | PHILIPS SITE VIEW WORKSTATION | Philips Medical Systems North America, Inc. | 1996-04-07 | Traditional | PDF ↗ |
| K954691 | ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM | Access Radiology Corp. | 1996-03-29 | Traditional | PDF ↗ |
| K954172 | X-RAY VISIONS | Image Visions, LLC | 1996-03-15 | Traditional | PDF ↗ |
| K955708 | COMPUMED DICON CLIENT | Compumed, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K954071 | IDXVIEW | Idx Systems Corp. | 1996-02-27 | Traditional | PDF ↗ |
| K954479 | DICOMVIEW | Heartlab, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K955000 | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | Cerner Corp. | 1996-01-26 | Traditional | PDF ↗ |
| K950513 | ARCHIVEMANAGER | Cemax, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K954008 | REDI-VU SYSTEMS (SEND & RECEIVE) | Jd Technical Services, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K953552 | SIENET SPI SPOOLER | Siemens Medical Solutions USA, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K953371 | LUMISYS DICOM TOOKLIT | Lumisys, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K953514 | COURIER II | Gammex, Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K953398 | UNISCAN | Merlin Engineering Works, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K953080 | DIGITAL IMAGING SYSTEM INTERFACE | Camtronics, Ltd. | 1995-09-28 | Traditional | PDF ↗ |
| K953163 | QUICK READ 2000 (QR2000) | Quicksilver Systems, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K952914 | STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM | Star Technologies, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K952533 | SIENET DICOM GATEWAY | Siemens AG | 1995-08-23 | Traditional | PDF ↗ |
| K951175 | MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS) | Sirius Corp. | 1995-06-30 | Traditional | PDF ↗ |
| K950413 | MEDIPACS | Nexsys Electronics | 1995-06-30 | Traditional | PDF ↗ |
| K952484 | MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A | Toshiba America Medical Systems, In.C | 1995-06-23 | Traditional | PDF ↗ |
| K943994 | PACS EQUIPMENT | Rstar Image Management System | 1995-05-12 | Traditional | PDF ↗ |
| K950431 | LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM | Open Mri, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K950699 | PREVIEW TELEIMAGING SYSTEM | Regulatory Management Services | 1995-05-03 | Traditional | PDF ↗ |
| K950343 | HYPERPACS PACS AND TELERAFIOLOGY SYSTEM | Rogan Imaging Corp. | 1995-04-12 | Traditional | PDF ↗ |
| K944322 | AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM | At&T Image Solutions | 1995-02-24 | Traditional | PDF ↗ |
| K925964 | IMAGE TRANSPORT SERIES III | Dataview Imaging Intl., Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K940859 | PACSPRO I | Advanced Video Products, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K944771 | INTRASCAN II | Markcare Medical Systems, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K944130 | RIT 531 TELERADIOLOGY/ PAC SYSTEM | Radiological Imaging Technology, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K941224 | LENZAR REMOTE ACQUISITION SYSTEM | Lenzar Electrooptics, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K942861 | MEDVISION ENVIROMENT/MEDVISION 2.0 | Evergreen Technologies, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K943158 | AD/V IMAGEPLEX(TM) | Adaptive Video, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K943383 | IMAGING WORKBENCH | Brit Systems, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K942917 | ULTRAPRO WORKSTATION | Ramsoft, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K940423 | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE | Advanced Technology Laboratories, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K941203 | MEDICAL IMAGING WORKSTATION II (MIW II) | Cemco, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K941086 | PACSPRO II | Advanced Video Products, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K940408 | REMOTE CONSOLE | Robinson Engineering Teleradiology System | 1994-06-08 | Traditional | PDF ↗ |
| K936153 | 3M 1156 MULTI-INPUT SYSTEM | 3M Information,Imaging and Electronic Sector | 1994-05-23 | Traditional | PDF ↗ |
| K936116 | KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS | Eastman Kodak Company | 1994-04-29 | Traditional | PDF ↗ |
| K935103 | VISIONLINK ACR-NEMA CONVERSION UTILITIES | Evergreen Technologies, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K934386 | IMPAX 5000 | Heraeus Kulzer, Inc. | 1994-01-05 | Traditional | PDF ↗ |
| K930500 | MAXIVIEW DIAGNOSTIC WORKSTATION | Dimensional Medicine, Inc. | 1993-12-29 | Traditional | PDF ↗ |
| K926315 | PRACTICE PARTNER | Rs Imaging | 1993-12-13 | Traditional | PDF ↗ |
| K931186 | PHOTOPHONE MULTIVIEW | Image Data Corp. | 1993-11-22 | Traditional | PDF ↗ |
| K931795 | TELERAD STAT | Magnetic Research, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K933409 | IMPAX 1000 | Heraeus Kulzer, Inc. | 1993-11-03 | Traditional | PDF ↗ |
Product code LMD · Class I · Radiology. Data: openFDA.