Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LMA — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
199 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132183 | DICOM VIDEO | Bar Code Computer, Ltd. | 2013-10-03 | 80 | 0 |
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Vidar Systems Corp. | 2013-06-07 | 88 | 0 |
| K130406 | DIAGNOSTICPRO EDGE | Vidar Systems Corp. | 2013-04-29 | 69 | 0 |
| K102476 | TELERADPRO | Vidar Systems Corp. | 2010-10-07 | 38 | 0 |
| K093809 | VIDAR DENTAL FILM DIGITIZER | Vidar Systems Corp. | 2010-01-07 | 29 | 0 |
| K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER | Microtek International, Inc. | 2009-08-14 | 105 | 0 |
| K063424 | FILM DIGITZER, MODEL 2908 MAMMO PRO | Array Corp. | 2006-12-21 | 38 | 0 |
| K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | Nai Technology Products | 2004-10-20 | 37 | 0 |
| K033637 | MEDICAL IMAGE DIGITIZER, MODEL 2908 | Array Corp. | 2003-12-17 | 28 | 0 |
| K032022 | DIGITAL IMAGER | Pyramid Medical, Inc. | 2003-09-02 | 64 | 0 |
| K022810 | COBRASCAN CR-1 FILMLESS | Radiographic Digital Imaging, Inc. | 2002-10-11 | 49 | 0 |
| K021949 | FULCRUM | Howtek, Inc. | 2002-08-12 | 60 | 0 |
| K020243 | LASERPRO 16 | Eradlink, Inc. | 2002-03-05 | 41 | 0 |
| K013631 | EFILM VIDEO | Efilm Medical, Inc. | 2001-11-20 | 15 | 0 |
| K013395 | LIFEJET VIDEO LINK | Ferrania S.P.A. | 2001-10-30 | 15 | 0 |
| K011049 | EXPRESSSUITE | Vidar Systems Corp. | 2001-10-01 | 178 | 0 |
| K001841 | 35/CD CINECONVERTER | Tagarno A/S | 2000-11-15 | 149 | 0 |
| K000411 | CHILI VIDEO, CHILI VIDEOPRO | Steinbeis-Transferzentrum Medizinische Informatik | 2000-04-14 | 66 | 0 |
| K992467 | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | Dba Systems, Inc. | 2000-02-10 | 202 | 0 |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY | Vidar Systems Corp. | 2000-01-20 | 87 | 0 |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOS | Vidar Systems Corp. | 2000-01-18 | 85 | 0 |
| K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619 | Vidar Systems Corp. | 1999-12-15 | 51 | 0 |
| K990066 | CCD CAMERA, MODEL 9000 | Camtronics, Ltd. | 1999-03-17 | 68 | 2 |
| K984409 | ELK LASER FILM DIGITIZER | Nishimoto Sangyo Co., Ltd. | 1999-02-12 | 65 | 0 |
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Imation Corp. | 1999-01-25 | 59 | 0 |
| K982785 | FILM DIGITIZER MODEL 2905 | Array Corp. | 1998-10-15 | 69 | 0 |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Konica Corp. | 1998-06-19 | 105 | 0 |
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | Lumisys, Inc. | 1998-05-11 | 69 | 0 |
| K974315 | VIDAR VXR LS LASER FILM DIGITIZER | Vidar Systems Corp. | 1998-04-17 | 151 | 0 |
| K980565 | LD2000 SERIES | General Scanning, Inc. | 1998-03-19 | 34 | 0 |
| K980213 | DI-2000 | Lumisys, Inc. | 1998-03-17 | 67 | 0 |
| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | Afp Imaging Corp. | 1998-02-25 | 76 | 0 |
| K973411 | DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) | General Scanning, Inc. | 1997-12-04 | 86 | 0 |
| K971894 | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM | Eastman Kodak Company | 1997-08-20 | 90 | 0 |
| K970908 | HOWTEK 960 | Howtek, Inc. | 1997-05-20 | 70 | 0 |
| K964288 | CALL-RAD PC TELERADIOLOGY | Pc Teleradiology | 1997-04-23 | 177 | 0 |
| K960839 | FILM SCANNER 300 | Cannon U.S.A., Inc. | 1996-12-18 | 296 | 0 |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM | Kodak Health Imaging Systems, Inc. | 1996-08-22 | 106 | 0 |
| K953117 | SCANMASTER DX | Howtek, Inc. | 1996-01-18 | 199 | 0 |
| K954875 | ASPECT ACQUISITION MODULE (AAM) | Aspect Electronics, Inc. | 1996-01-02 | 70 | 0 |
| K953942 | COBRASCAN CX-312 | Radiographic Digital Imaging, Inc. | 1995-12-22 | 141 | 0 |
| K952485 | LASERNET IMAGE MANAGER/PRINT SERVER | Frantz Imaging, Inc. | 1995-11-24 | 178 | 0 |
| K953964 | LUMISYS, LUMISCAN 20 | Lumisys, Inc. | 1995-09-18 | 27 | 0 |
| K943357 | CEMAX SCANLINK V | Cemax, Inc. | 1994-11-22 | 133 | 0 |
| K932760 | DFS-2100 | Dba Systems, Inc. | 1994-10-20 | 499 | 0 |
| K925799 | AD/V A.5 | Adaptive Video, Inc. | 1994-02-18 | 459 | 0 |
| K933830 | KONICA LD-4500 LASER DIGITIZER | Konica Medical Corp. | 1993-12-14 | 131 | 0 |
| K933632 | MEDSCAN 12 | Vidar Systems Corp. | 1993-12-13 | 139 | 0 |
| K933129 | LUMISCAN 50 | Lumisys, Inc. | 1993-10-07 | 101 | 0 |
| K925721 | KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE | Eastman Kodak Company | 1993-02-26 | 106 | 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