Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LMD — Predicate Candidate Screening
142 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
221 days90th percentile
142clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | Terarecon,Inc. | 2000-05-26 | 156 | 0 |
| K992698 | STENTOR, PAGEVIEW | Stentor, Inc. | 1999-10-25 | 75 | 0 |
| K992426 | RAYPAX WEB CLINICAL SYSTEM | Samsung Sds Co., Ltd. | 1999-10-13 | 84 | 0 |
| K992352 | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | Inteleradiology, Inc. | 1999-09-29 | 77 | 0 |
| K991537 | SAMSUNG RAYPAX SYSTEM | Samsung Sds Co., Ltd. | 1999-07-06 | 64 | 0 |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-12 | 63 | 0 |
| K974707 | IMAGEQUEST | Visual Med, Inc. | 1998-07-31 | 227 | 0 |
| K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW | Eastman Kodak Company | 1998-06-18 | 87 | 0 |
| K980918 | JPACS | Philips Medical Systems (Cleveland), Inc. | 1998-06-03 | 84 | 0 |
| K974882 | DOWNSCAN LT | Merlin Engineering Works, Inc. | 1998-05-22 | 143 | 0 |
| K980684 | VR NETSERVE | I.S.G. Technologies, Inc. | 1998-05-06 | 72 | 0 |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | Barco NV Display Systems | 1998-04-09 | 57 | 0 |
| K980241 | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE | Netco Communications Corp. | 1998-03-17 | 53 | 0 |
| K980220 | IISYS PACS SYSTEM | Sterling Diagnostic Imaging, Inc. | 1998-02-13 | 22 | 0 |
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM | Dejarnette Research Systems | 1998-01-29 | 87 | 0 |
| K974255 | CD-R STATION AND VRS-2000 | Electromed Intl., Ltd. | 1998-01-27 | 75 | 0 |
| K974107 | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) | Eastman Kodak Company | 1998-01-21 | 82 | 0 |
| K974102 | MILTRA IMAGING INC., IMAGE VAULT | Mitra Imaging, Inc. | 1998-01-20 | 81 | 0 |
| K973805 | IMAGEACCESS SYSTEM | Storcomm, Inc. | 1998-01-02 | 88 | 0 |
| K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | Barco NV Display Systems | 1998-01-02 | 168 | 0 |
| K973959 | OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW | Olicon Imaging Systems, Inc. | 1997-12-22 | 67 | 0 |
| K973793 | OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE | Olicon Imaging Systems, Inc. | 1997-12-17 | 72 | 0 |
| K972925 | ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION | Access Radiology Corp. | 1997-12-05 | 119 | 0 |
| K973421 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR S | Dejarnette Research Systems | 1997-12-05 | 86 | 0 |
| K973239 | DICOM 3.0 SOFTWARE VERSION 2.0 | Adac Laboratories | 1997-11-26 | 90 | 0 |
| K973303 | IMATION MODEL 9410 NETWORK INTERFACE | Imation Corp. | 1997-11-25 | 83 | 0 |
| K973131 | SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWA | Siemens Medical Solutions USA, Inc. | 1997-11-12 | 83 | 0 |
| K973090 | MEDSTATION | Program S.R.L. | 1997-10-28 | 71 | 0 |
| K972366 | IMNET DICOM NETWORK AGENT | Imnet Systems, Inc. | 1997-09-23 | 90 | 0 |
| K972191 | DIGITIZER DIRECTOR (HSC025-01) | Howtek, Inc. | 1997-09-08 | 90 | 0 |
| K971347 | MEDISURF | International Regulatory Consultants | 1997-07-03 | 84 | 0 |
| K971154 | MULTIPICS(ME-977) | Merlin Engineering Works, Inc. | 1997-06-25 | 89 | 0 |
| K971153 | SPLITSCREEN (ME-975) | Merlin Engineering Works, Inc. | 1997-06-25 | 89 | 0 |
| K970628 | GE ADVANTAGE DIGITIZER WORKSTATION | Ge Medical Systems, Inc. | 1997-05-12 | 82 | 0 |
| K970652 | MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE | Mitra Imaging, Inc. | 1997-05-02 | 70 | 0 |
| K970641 | RIS SCANVIEW SYSTEM (RSVS) | Radiology Information Systems, Inc. | 1997-05-02 | 71 | 0 |
| K970174 | FREEPIX/PIXPACS DICOM/HTTP GATEWAY | Pixelinks, Inc. | 1997-05-01 | 111 | 0 |
| K970293 | FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 | Fujifilm Medical System U.S.A., Inc. | 1997-03-21 | 56 | 0 |
| K970064 | AMICAS WEB/INTRANET IMAGE SERVER | Autocyt Group, Inc. | 1997-03-17 | 69 | 0 |
| K965161 | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) | Sectra-Imtec AB | 1997-03-12 | 79 | 0 |
| K964250 | LINX NETWORKING SYSTEM | Sterling Diagnostic Imaging, Inc. | 1996-12-18 | 55 | 0 |
| K963861 | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE | Dejarnette Research Systems | 1996-12-18 | 85 | 0 |
| K963592 | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 | Dejarnette Research Systems | 1996-11-07 | 59 | 0 |
| K963594 | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFT | Dejarnette Research Systems | 1996-11-07 | 59 | 0 |
| K963628 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR S | Dejarnette Research Systems | 1996-11-07 | 57 | 0 |
| K962225 | VIEWSEND MEDICAL MODEL 1200 | Klt Telecom, Inc. | 1996-10-25 | 137 | 0 |
| K961023 | AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) | Accuimage, Inc. | 1996-09-09 | 179 | 0 |
| K962699 | RADWORKS MEDICAL IMAGING SOFTWARE | Applicare Medical Imaging, B.V. | 1996-08-19 | 39 | 0 |
| K961689 | INFINET | Infimed, Inc. | 1996-07-31 | 91 | 0 |
| K961753 | SHARED VISION(PART NUMBER SV 0015) | Imagelabs, Inc. | 1996-07-25 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda