Atlas FDA

LMB

55 FDA 510(k) clearances · Product code

87 daysmedian time to decision
286 days90th percentile
55clearances measured

FDA profile

Official device name
Device, Digital Image Storage, Radiological
Device class
Class I (low risk)
Regulation
21 CFR 892.2010
Medical specialty
Radiology
FDA definition
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Adverse events (MAUDE)
2008: 3 · 2009: 3 · 2010: 16 · 2013: 7 · 2016: 21 · 2017: 10
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
SAMSUNG RAYPAX LONG TERM ARCHIVE (K992131)Samsung Sds Co., Ltd.1999-09-13
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (K984405)Intracom Corp.1999-02-08
WISE (II) IMAGE MANAGEMENT SYSTEM (K983447)Sectra-Imtec AB1998-10-29
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (K980243)Parameter Developments, Inc.1998-04-03
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463)O Tech, Inc.1997-12-02
ID. STORE (RELEASE 2.0) (K973413)I.S.G. Technologies, Inc.1997-11-25
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380)Eastman Kodak Company1997-09-11
TDK MEDICAL GRADE CD-R (K971848)Tdk Electronics Corporation of America1997-08-15
WISE IMAGE MANAGEMENT SYSTEM (K971451)O Tech, Inc.1997-06-26
ACCESSPOINT, MED E-MAIL, DICOM READER (K963936)Biosound, Inc.1997-03-31
UNIVISION ECHOCARDIOLOGY SYSTEM (K964803)Network Concepts, Inc.1997-02-11
WRITESTAR, AND VIEWSTAR (K964274)Comview Corp.1997-01-10
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM (K963395)Sectra-Imtec AB1996-10-25
SONY DKR-700 DIGITAL STILL RECORDER (K961680)Sony Medical Systems1996-07-03
UPACS VERSION 1.7 (K961160)Base Ten Systems, Inc.1996-06-11
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (K960981)Kodak Health Imaging Systems, Inc.1996-06-07
UPACS (K960941)Base Ten Systems, Inc.1996-06-03
LAST IMAGE HOLD (K951942)Insight Systems1996-04-08
TIGERSCAN/TIGERVIEW (K955237)Tau Corp.1996-04-04
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM (K960326)Fujifilm Medical System U.S.A., Inc.1996-03-07
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) (K952238)Imaging Concepts, Inc.1996-02-21
ACCULUPE (K955184)E For M Imaging Systems Div., Marquette Electronic1996-01-24
NT SERIES DIGITAL IMAGE MANAGER (K955232)Camtronics, Ltd.1995-12-11
WALLACH DIGITAL IMAGING SYSTEM (K950630)Wallach Surgical Devices, Inc.1995-11-22
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS (K952888)Olympus America, Inc.1995-09-18
TOMTECP90 (K950279)Tomtec Imaging Systems, Inc.1995-09-15
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER (K951141)Star Technologies, Inc.1995-05-30
INSTACINE (K942558)Fidelity Medical, Inc.1995-05-30
NICOM DIGITAL IMAGE MANAGER (K945654)Camtronics, Ltd.1995-02-17
DIGITAL DISK RECORDER (K933115)Eigen1994-04-07
7500 DATA TOWER (K935498)E-Systems, Inc.1994-04-01
NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM (K931410)Novus Technologies, Inc.1994-02-18
OLYMPUS IMAGEMANAGER SYSTEM (K934889)Olympus1994-01-28
OLYMPUS IMAGEMANAGERSYSTEM (K934888)Olympus1994-01-25
SC1000 SCAN CONVERTER (K926348)Perkins Mfg. Co.1993-11-19
ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM (K923680)Minnetonka Medical1992-10-20
SONY LASER VIDEODISC RECORDING SYSTEM (K921275)Sony Medical Systems1992-06-10
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM (K914728)Eastman Kodak Company1992-03-02
VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM (K915094)Vortech Data, Inc.1991-12-27
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (K905488)Ausonics Pty , Ltd.1991-12-18
ANGIOTEC IMAGE MANAGEMENT SYSTEM (K903806)Andros Analyzers, Inc.1990-11-23
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) (K901956)Eigen1990-07-02
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM (K901118)Adac Laboratories1990-04-10
KODAK EKTASCAN IMAGE MANAGER (K891690)Eastman Kodak Company1989-06-15
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM (K885327)Philips Medical Systems North America, Inc.1989-05-11
ANGIOTEC FMX-2220 SYSTEM (K891485)Andros Analyzers, Inc.1989-05-05
IMS-3 PICTURE ARCHIVING SYSTEM (K884990)The Biomedical Engineering Center1989-03-23
DISKCAM DC 6001 (K884148)Camtronics, Ltd.1988-11-23
HR-1000 W/SUFFIXES (B,C OR D) (K882184)Eigen1988-06-28
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET (K873048)Eastman Kodak Company1987-10-30
ERS SYSTEM (K863286)General Electric Co.1986-10-27
ADVANCED NUCLEAR COMPUTER (K862842)Advanced Nuclear Imaging Corp.1986-10-27
MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER (K844132)Sigma Teleproducts, Inc.1985-01-22
ND3100 VIDEO IMAGER (K843349)Nuclear Data, Inc.1984-12-17
CEMAX-1000 (K833525)Contour Medical Systems, Inc.1983-11-21

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