Atlas FDA

LMA

61 FDA 510(k) clearances · Product code

85 daysmedian time to decision
199 days90th percentile
61clearances measured

FDA profile

Official device name
Digitizer, Image, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2030
Medical specialty
Radiology
Adverse events (MAUDE)
2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DICOM VIDEO (K132183)Bar Code Computer, Ltd.2013-10-03
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (K130636)Vidar Systems Corp.2013-06-07
DIAGNOSTICPRO EDGE (K130406)Vidar Systems Corp.2013-04-29
TELERADPRO (K102476)Vidar Systems Corp.2010-10-07
VIDAR DENTAL FILM DIGITIZER (K093809)Vidar Systems Corp.2010-01-07
MEDI-6000 MEDICAL IMAGE DIGITIZER (K091288)Microtek International, Inc.2009-08-14
FILM DIGITZER, MODEL 2908 MAMMO PRO (K063424)Array Corp.2006-12-21
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (K042484)Nai Technology Products2004-10-20
MEDICAL IMAGE DIGITIZER, MODEL 2908 (K033637)Array Corp.2003-12-17
DIGITAL IMAGER (K032022)Pyramid Medical, Inc.2003-09-02
COBRASCAN CR-1 FILMLESS (K022810)Radiographic Digital Imaging, Inc.2002-10-11
FULCRUM (K021949)Howtek, Inc.2002-08-12
LASERPRO 16 (K020243)Eradlink, Inc.2002-03-05
EFILM VIDEO (K013631)Efilm Medical, Inc.2001-11-20
LIFEJET VIDEO LINK (K013395)Ferrania S.P.A.2001-10-30
EXPRESSSUITE (K011049)Vidar Systems Corp.2001-10-01
35/CD CINECONVERTER (K001841)Tagarno A/S2000-11-15
CHILI VIDEO, CHILI VIDEOPRO (K000411)Steinbeis-Transferzentrum Medizinische Informatik2000-04-14
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM (K992467)Dba Systems, Inc.2000-02-10
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 (K993598)Vidar Systems Corp.2000-01-20
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 (K993599)Vidar Systems Corp.2000-01-18
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 (K993597)Vidar Systems Corp.1999-12-15
CCD CAMERA, MODEL 9000 (K990066)Camtronics, Ltd.1999-03-17
ELK LASER FILM DIGITIZER (K984409)Nishimoto Sangyo Co., Ltd.1999-02-12
IMATION TRIMATIC DIGITAL SYSTEM (K984252)Imation Corp.1999-01-25
FILM DIGITIZER MODEL 2905 (K982785)Array Corp.1998-10-15
KONICA DIRECT DIGITIZER REGIUS MODEL 330 (K980873)Konica Corp.1998-06-19
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER (K980809)Lumisys, Inc.1998-05-11
VIDAR VXR LS LASER FILM DIGITIZER (K974315)Vidar Systems Corp.1998-04-17
LD2000 SERIES (K980565)General Scanning, Inc.1998-03-19
DI-2000 (K980213)Lumisys, Inc.1998-03-17
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM (K974619)Afp Imaging Corp.1998-02-25
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) (K973411)General Scanning, Inc.1997-12-04
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM (K971894)Eastman Kodak Company1997-08-20
HOWTEK 960 (K970908)Howtek, Inc.1997-05-20
CALL-RAD PC TELERADIOLOGY (K964288)Pc Teleradiology1997-04-23
FILM SCANNER 300 (K960839)Cannon U.S.A., Inc.1996-12-18
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) (K961768)Kodak Health Imaging Systems, Inc.1996-08-22
SCANMASTER DX (K953117)Howtek, Inc.1996-01-18
ASPECT ACQUISITION MODULE (AAM) (K954875)Aspect Electronics, Inc.1996-01-02
COBRASCAN CX-312 (K953942)Radiographic Digital Imaging, Inc.1995-12-22
LASERNET IMAGE MANAGER/PRINT SERVER (K952485)Frantz Imaging, Inc.1995-11-24
LUMISYS, LUMISCAN 20 (K953964)Lumisys, Inc.1995-09-18
CEMAX SCANLINK V (K943357)Cemax, Inc.1994-11-22
DFS-2100 (K932760)Dba Systems, Inc.1994-10-20
AD/V A.5 (K925799)Adaptive Video, Inc.1994-02-18
KONICA LD-4500 LASER DIGITIZER (K933830)Konica Medical Corp.1993-12-14
MEDSCAN 12 (K933632)Vidar Systems Corp.1993-12-13
LUMISCAN 50 (K933129)Lumisys, Inc.1993-10-07
KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE (K925721)Eastman Kodak Company1993-02-26
MTV-250A, MTV-300A (K924478)Toshiba America Medical Systems, In.C1992-12-04
REAL TIME X-RAY IMAGING SYSTEM (K911082)Siemens Medical Solutions USA, Inc.1991-05-01
DIGITAL IMAGE SCANNER, MODEL DIS-1000 (K901423)Lumisys, Inc.1990-04-30
KONICA KFDR-S (K896739)Konica Medical Corp.1990-04-30
PHOTOPHONE (K896223)Image Data Corp.1990-02-12
RADIOSCOPE OR MAMMOSCOPE (K894412)Vision Ten, Inc.1989-12-22
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER (K890970)Truvel Corp.1989-05-11
THE SPANTRON FRAME FREEZE (K890477)Spantron, Inc.1989-03-31
KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR (K874778)Eastman Kodak Company1989-02-23
MATRIX LD & LD/LASER DIGITIZER (K860777)Matrix Instruments1987-04-22
ANGIOTEC SC 1221 SCAN CONVERTER (K850330)Angiotec1985-04-30

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Every clearance here is in the API, with alerts when new ones post.