Atlas FDA

LMC

121 FDA 510(k) clearances · Product code

74 daysmedian time to decision
206 days90th percentile
121clearances measured

FDA profile

Official device name
Camera, Multi Format, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2040
Medical specialty
Radiology
Adverse events (MAUDE)
1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (K141454)Sony Electronics, Inc.2014-06-26
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (K141346)Sony Electronics, Inc.2014-06-26
DRYVIEW CHROMA IMAGING SYSTEM (K111566)Carestream Health, Inc.2011-10-06
CYPHER DICOM PRINT SOLUTION (K092280)Virtual Imaging, Inc.2009-10-16
CARESTREAM DRYVIEW 5850 LASER IMAGER (K090469)Carestream Health, Inc.2009-05-22
SONY UP-DF750 DIGITAL FILM IMAGER (K083522)Sony Electronics, Inc.2009-01-09
LASER IMAGER DRYPRO MODEL 873 (K081637)Konica Minolta Medical & Graphic, Inc.2008-07-01
DRYSTAR AXYS, MODEL EYZ4E (K072680)Agfa Healthcare Corporation2007-10-25
DRY LASER IMAGER, DRYPRO MODEL 832 (K061999)Konica Minolta Medical & Graphic, Inc.2006-08-15
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (K061302)Mitsubishi Electric Corporation Kyoto Works2006-06-23
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER (K060440)Codonics, Inc.2006-03-16
DRYSTAR MODEL 5500 (K052251)Agfa Corporation2005-08-31
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 (K042133)Konica Minolta Medical & Graphic, Inc.2004-11-24
NP-2600 SERIES HARDCOPY PRINTERS (K042232)Codonics, Inc.2004-10-05
KODAK COLOR MEDICAL IMAGER 1000 (K042159)Eastman Kodak Company2004-09-24
KODAK MEDICAL IMAGER 300 (K042158)Eastman Kodak Company2004-09-24
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY (K033821)Eastman Kodak Company2004-02-20
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L (K033377)Fujifilm Medical System U.S.A., Inc.2004-01-09
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 (K032681)Konica Medical and Graphic Corporation2003-09-24
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 (K032635)Agfa Corp.2003-09-24
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS (K030690)Codonics, Inc.2003-04-30
UP-DF500 FILMSTATION DIGITAL FILM IMAGER (K024188)Sony Medical Systems2003-02-04
DRYSTAR 5500 (K023287)Agfa Corp.2002-10-22
LR DICOM CONTROLLER (K022658)Agfa Corp.2002-09-06
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER (K021054)Codonics, Inc.2002-05-09
KONICA LASER IMAGER, DRYPRO MODEL 751/752 (K013052)Konica Minolta Medical & Graphic, Inc.2002-01-16
DRYSTAR, MODEL 4500M (K012941)Agfa Corp.2001-11-29
MODIFICATION TO LR 5200 FILM RECORDER (K012010)Agfa Corp.2001-09-20
ELK LASER IMAGER, MODEL EL-DRY 4000 (K011949)Nishimoto Sangyo Co., Ltd.2001-08-29
LIFEJET PRINTER 400 (K011617)Ferrania S.P.A. Stabilimento DI Ferrania2001-06-08
DRYSTAR 4500 PRINTER, MODEL 4500 (K010275)Agfa Medical Imaging2001-04-27
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 (K003481)Codonics, Inc.2001-01-19
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY (K002146)Eastman Kodak Company2000-09-27
KONICA LASER IMAGER, DRYPRO MODEL 722 (K992586)Konica Corp.1999-10-29
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES (K991282)Seiko Instruments USA, Inc.1999-06-30
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 (K983905)Eastman Kodak Company1999-01-25
IMATION SE-204 LASER IMAGER (K972822)Imation Enterprises Corp.1997-11-19
RAVEN DRY PRINTER (K972660)Sterling Diagnostic Imaging, Inc.1997-11-10
HELIOS LASER IMAGER 1417 (K973028)Sterling Diagnostic Imaging, Inc.1997-10-28
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) (K973422)Dejarnette Research Systems1997-10-28
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) (K972847)Eastman Kodak Company1997-10-07
COLORPOINT OR PROFESSIONAL COLORPOINT (K971760)Seiko Instruments USA, Inc.1997-10-01
IMATION SE-196 LASER IMAGER (K972163)Imation Corp.1997-09-05
LR 5200 LASER FILM RECORDER (K964414)Bayer Corp., Agfa Div.1997-01-27
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) (K962364)Codonics, Inc.1996-11-08
FUJI MEDICAL DRY IMAGER FM-DP 2636 (K962967)Fujifilm Medical System U.S.A., Inc.1996-10-28
ASPECT OPTICAM (K962051)Aspect Electronics, Inc.1996-08-23
ULTRA COMPACT VIDEO IMAGER (K953165)International Imaging Electronics1996-05-07
SIENET TELERADIOLOGY PRODUCT LINE (K955394)Siemens Medical Solutions USA, Inc.1996-02-21
ASPECT DIGITAL FORMATTER (K954149)Aspect Electronics, Inc.1995-11-13
MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING (K953477)The DU Pont Co.1995-10-07
CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING (K953475)The DU Pont Co.1995-10-07
VOXCAM (K954198)Voxel1995-09-29
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER (K951807)Kodak Health Imaging Systems, Inc.1995-09-13
KODAK XLS 8600 (PS) (K951948)Kodak Health Imaging Systems, Inc.1995-09-13
KONICA LASER IMAGER LI-21 (K950359)Storch Amini & Munves PC1995-09-06
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L (K950721)Fujifilm Medical System U.S.A., Inc.1995-05-24
MINI IMAGER (K950423)Regulatory Management Services1995-05-12
FIKO FO;, TJER,A; O,AGER FTO-1000 (K950610)Fujifilm Medical System U.S.A., Inc.1995-04-25
AUTOLASER MULTI FORMAT CAMERA (K950288)Afp Imaging Corp.1995-04-04
FUJI MEDICAL LASER IMAGER FL-IM D (K945475)Fujifilm Medical System U.S.A., Inc.1995-03-09
3M 1152 LASER IMAGER (K936152)3M Information,Imaging and Electronic Sector1994-09-21
3M 1154 LASER IMAGER (K936142)3M Information,Imaging and Electronic Sector1994-09-16
MODEL FORTY ULTRA COMPACT VIDEO IMAGER (K940332)International Imaging Electronics1994-06-08
ULTRA COMPACT VIDEO IMAGER (K930755)International Imaging Electronics1993-09-28
IMAGEVIEW 5000 (K925650)Nuclear Data Systems1993-09-14
IMAGEVIEW 46000 (K925265)Canberra Industries, Inc.1993-06-09
PMI100 VIDEO IMAGER (K925220)Heraeus Kulzer, Inc.1993-05-20
PHILIPS LASER DISK ARCHIVE (K923481)Philips Medical Systems, Inc.1993-05-05
MATRIX CR 2050, PMI 3000 (K925289)Heraeus Kulzer, Inc.1993-04-08
LASERSTAR IMAGER (K921215)Frantz Imaging, Inc.1993-02-05
NUCLEAR MEDICINE LASER IMAGER (K923536)General Scanning, Inc.1992-11-30
HARRIS MODEL 2000 (K921906)Harris Mfg. Co.1992-11-02
MEDGRAPHIX INTL VR 1000 SERIES (K921381)Medgraphix Intl.1992-11-02
3M COLOR LASER IMAGER, MODEL 979 (K923222)3M Medical Products Group1992-09-30
3M LASER IMAGER MODEL 969 (K923075)3M Medical Products Group1992-09-23
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 (K922411)Eastman Kodak Company1992-08-24
MP3000 SERIES III VIDEO IMAGER (K921992)International Imaging Electronics1992-07-10
KODAK EKTASCAN 2180 LASER PRINTER (K921743)Eastman Kodak Company1992-07-01
KONICA LI 10 AND 10A LASER IMAGER (K920769)Konica Corp.1992-05-06
VORTECH 3M NETWORK PRINTING (K914834)Vortech Data, Inc.1992-03-06
KODAK EKTASCAN 1120 LASER PRINTER (K914582)Eastman Kodak Company1991-12-19
EAGLE SYSTEM (K912799)Marquette Electronics, Inc.1991-12-18
POLAROID HELIOS LASER IMAGER (K912073)Polaroid Medical Corp.1991-08-28
KODAK EKTASCAN CABLE EXTENSION (K911437)Eastman Kodak Company1991-05-17
3M LASER IMAGER XL (K910092)3M Medical Products Group1991-04-08
COMPACT LASER IMAGER, MODEL CLI-100 (K902347)Lumisys, Inc.1991-03-04
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS (K905566)Eastman Kodak Company1991-01-03
MODEL 400 ULTRA COMPACT VIDEO IMAGER (K904897)International Imaging Electronics1990-11-20
MULTI FORMAT VIDEO IMAGER 600 PLUS (K904363)International Imaging Electronics1990-11-13
AFGA VIDEO IMAGER, VARIOUS MODELS (K903238)Enhanced Imaging Technologies, Inc.1990-11-02
MP3000 COMPACT VIDEO IMAGER (K900899)International Imaging Electronics1990-04-30
MP4000 SERIES II COMPACT VIDEO IMAGER (K900901)International Imaging Electronics1990-04-30
MP3000 SERIES II COMPACT VIDEO IMAGER (K900900)International Imaging Electronics1990-04-30
6000 PLUS MULTI-FORMAT VIDEO IMAGER (K900896)International Imaging Electronics1990-04-30
9000 ECONOMICAL 14 X 17 VIDEO IMAGER (K900898)International Imaging Electronics1990-04-19
5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI. (K900897)International Imaging Electronics1990-04-19
FUJI MEDICAL LASER IMAGER (K900885)Fujifilm Medical System U.S.A., Inc.1990-03-23
COMPACT VIDEO IMAGER MP4000 SERIES III (K896683)International Imaging Electronics1990-01-22
DIGICAM LHP (VIDEO INTERFACE OPTION) (K895668)Siemens Gammasonics, Inc.1989-11-15
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