Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LMC — Predicate Candidate Screening
121 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
206 days90th percentile
121clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141454 | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | Sony Electronics, Inc. | 2014-06-26 | 24 | 0 |
| K141346 | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP | Sony Electronics, Inc. | 2014-06-26 | 35 | 0 |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | Carestream Health, Inc. | 2011-10-06 | 122 | 0 |
| K092280 | CYPHER DICOM PRINT SOLUTION | Virtual Imaging, Inc. | 2009-10-16 | 80 | 0 |
| K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | Carestream Health, Inc. | 2009-05-22 | 88 | 0 |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | Sony Electronics, Inc. | 2009-01-09 | 44 | 0 |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | Konica Minolta Medical & Graphic, Inc. | 2008-07-01 | 20 | 0 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Agfa Healthcare Corporation | 2007-10-25 | 31 | 1 |
| K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | Konica Minolta Medical & Graphic, Inc. | 2006-08-15 | 32 | 0 |
| K061302 | DIGITAL PRINTER P6000D SERIES, MODEL P6000DU | Mitsubishi Electric Corporation Kyoto Works | 2006-06-23 | 44 | 0 |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONIC | Codonics, Inc. | 2006-03-16 | 23 | 0 |
| K052251 | DRYSTAR MODEL 5500 | Agfa Corporation | 2005-08-31 | 13 | 0 |
| K042133 | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 | Konica Minolta Medical & Graphic, Inc. | 2004-11-24 | 107 | 0 |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | Codonics, Inc. | 2004-10-05 | 49 | 0 |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Eastman Kodak Company | 2004-09-24 | 45 | 0 |
| K042158 | KODAK MEDICAL IMAGER 300 | Eastman Kodak Company | 2004-09-24 | 45 | 0 |
| K033821 | KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY | Eastman Kodak Company | 2004-02-20 | 73 | 0 |
| K033377 | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5 | Fujifilm Medical System U.S.A., Inc. | 2004-01-09 | 79 | 0 |
| K032681 | KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 | Konica Medical and Graphic Corporation | 2003-09-24 | 26 | 0 |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | Agfa Corp. | 2003-09-24 | 29 | 0 |
| K030690 | CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS | Codonics, Inc. | 2003-04-30 | 56 | 0 |
| K024188 | UP-DF500 FILMSTATION DIGITAL FILM IMAGER | Sony Medical Systems | 2003-02-04 | 47 | 0 |
| K023287 | DRYSTAR 5500 | Agfa Corp. | 2002-10-22 | 20 | 0 |
| K022658 | LR DICOM CONTROLLER | Agfa Corp. | 2002-09-06 | 28 | 0 |
| K021054 | CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS | Codonics, Inc. | 2002-05-09 | 38 | 0 |
| K013052 | KONICA LASER IMAGER, DRYPRO MODEL 751/752 | Konica Minolta Medical & Graphic, Inc. | 2002-01-16 | 127 | 0 |
| K012941 | DRYSTAR, MODEL 4500M | Agfa Corp. | 2001-11-29 | 90 | 0 |
| K012010 | MODIFICATION TO LR 5200 FILM RECORDER | Agfa Corp. | 2001-09-20 | 85 | 0 |
| K011949 | ELK LASER IMAGER, MODEL EL-DRY 4000 | Nishimoto Sangyo Co., Ltd. | 2001-08-29 | 69 | 0 |
| K011617 | LIFEJET PRINTER 400 | Ferrania S.P.A. Stabilimento DI Ferrania | 2001-06-08 | 14 | 0 |
| K010275 | DRYSTAR 4500 PRINTER, MODEL 4500 | Agfa Medical Imaging | 2001-04-27 | 87 | 0 |
| K003481 | CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 | Codonics, Inc. | 2001-01-19 | 71 | 0 |
| K002146 | KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY | Eastman Kodak Company | 2000-09-27 | 72 | 0 |
| K992586 | KONICA LASER IMAGER, DRYPRO MODEL 722 | Konica Corp. | 1999-10-29 | 88 | 0 |
| K991282 | COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-100 | Seiko Instruments USA, Inc. | 1999-06-30 | 77 | 0 |
| K983905 | KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK | Eastman Kodak Company | 1999-01-25 | 83 | 0 |
| K972822 | IMATION SE-204 LASER IMAGER | Imation Enterprises Corp. | 1997-11-19 | 112 | 0 |
| K972660 | RAVEN DRY PRINTER | Sterling Diagnostic Imaging, Inc. | 1997-11-10 | 117 | 0 |
| K973028 | HELIOS LASER IMAGER 1417 | Sterling Diagnostic Imaging, Inc. | 1997-10-28 | 75 | 0 |
| K973422 | LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT] | Dejarnette Research Systems | 1997-10-28 | 48 | 0 |
| K972847 | KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) | Eastman Kodak Company | 1997-10-07 | 67 | 0 |
| K971760 | COLORPOINT OR PROFESSIONAL COLORPOINT | Seiko Instruments USA, Inc. | 1997-10-01 | 142 | 0 |
| K972163 | IMATION SE-196 LASER IMAGER | Imation Corp. | 1997-09-05 | 88 | 0 |
| K964414 | LR 5200 LASER FILM RECORDER | Bayer Corp., Agfa Div. | 1997-01-27 | 83 | 1 |
| K962364 | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) | Codonics, Inc. | 1996-11-08 | 142 | 0 |
| K962967 | FUJI MEDICAL DRY IMAGER FM-DP 2636 | Fujifilm Medical System U.S.A., Inc. | 1996-10-28 | 90 | 0 |
| K962051 | ASPECT OPTICAM | Aspect Electronics, Inc. | 1996-08-23 | 87 | 0 |
| K953165 | ULTRA COMPACT VIDEO IMAGER | International Imaging Electronics | 1996-05-07 | 305 | 0 |
| K955394 | SIENET TELERADIOLOGY PRODUCT LINE | Siemens Medical Solutions USA, Inc. | 1996-02-21 | 89 | 2 |
| K954149 | ASPECT DIGITAL FORMATTER | Aspect Electronics, Inc. | 1995-11-13 | 69 | 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