Device, Digital Image Storage, Radiological
Regulation 892.2010
0510(k)s in 12 months (55 all time)
0recalls in 12 months (19 all time)
4recalls that name a 510(k)
Top companies in LMB
| Company | 510(k)s | Recalls |
|---|---|---|
| Merge Healthcare, Inc. | 0 | 5 |
| Eastman Kodak Company | 4 | 0 |
| Camtronics, Ltd. | 3 | 0 |
| Eigen | 3 | 0 |
| Olympus America, Inc. | 1 | 2 |
| Stryker Imaging | 0 | 3 |
| Andros Analyzers, Inc. | 2 | 0 |
| Base Ten Systems, Inc. | 2 | 0 |
| Ge Healthcare It | 0 | 2 |
| O Tech, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 1999 | K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE Samsung Sds Co., Ltd. | LMB |
| Feb 8, 1999 | K984405 | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 Intracom Corp. | LMB |
| Oct 29, 1998 | K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM Sectra-Imtec AB | LMB |
| Apr 3, 1998 | K980243 | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) Parameter Developments, Inc. | LMB |
| Dec 2, 1997 | K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE O Tech, Inc. | LMB |
| Nov 25, 1997 | K973413 | ID. STORE (RELEASE 2.0) I.S.G. Technologies, Inc., CA | LMB |
| Sep 11, 1997 | K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) Eastman Kodak Company | LMB |
| Aug 15, 1997 | K971848 | TDK MEDICAL GRADE CD-R Tdk Electronics Corporation of America | LMB |
| Jun 26, 1997 | K971451 | WISE IMAGE MANAGEMENT SYSTEM O Tech, Inc. | LMB |
| Mar 31, 1997 | K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER Biosound, Inc. | LMB |
| Feb 11, 1997 | K964803 | UNIVISION ECHOCARDIOLOGY SYSTEM Network Concepts, Inc. | LMB |
| Jan 10, 1997 | K964274 | WRITESTAR, AND VIEWSTAR Comview Corp. | LMB |
| Oct 25, 1996 | K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM Sectra-Imtec AB | LMB |
| Jul 3, 1996 | K961680 | SONY DKR-700 DIGITAL STILL RECORDER Sony Medical Systems | LMB |
| Jun 11, 1996 | K961160 | UPACS VERSION 1.7 Base Ten Systems, Inc. | LMB |
| Jun 7, 1996 | K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY Kodak Health Imaging Systems, Inc. | LMB |
| Jun 3, 1996 | K960941 | UPACS Base Ten Systems, Inc. | LMB |
| Apr 8, 1996 | K951942 | LAST IMAGE HOLD Insight Systems | LMB |
| Apr 4, 1996 | K955237 | TIGERSCAN/TIGERVIEW Tau Corp. | LMB |
| Mar 7, 1996 | K960326 | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM Fujifilm Medical System U.S.A., Inc. | LMB |
| Feb 21, 1996 | K952238 | VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) Imaging Concepts, Inc. | LMB |
| Jan 24, 1996 | K955184 | ACCULUPE E For M Imaging Systems Div., Marquette Electronic | LMB |
| Dec 11, 1995 | K955232 | NT SERIES DIGITAL IMAGE MANAGER Camtronics, Ltd. | LMB |
| Nov 22, 1995 | K950630 | WALLACH DIGITAL IMAGING SYSTEM Wallach Surgical Devices, Inc. | LMB |
| Sep 18, 1995 | K952888 | OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS Olympus America, Inc. | LMB |
| Sep 15, 1995 | K950279 | TOMTECP90 Tomtec Imaging Systems, Inc. | LMB |
| May 30, 1995 | K951141 | STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER Star Technologies, Inc. | LMB |
| May 30, 1995 | K942558 | INSTACINE Fidelity Medical, Inc. | LMB |
| Feb 17, 1995 | K945654 | NICOM DIGITAL IMAGE MANAGER Camtronics, Ltd. | LMB |
| Apr 7, 1994 | K933115 | DIGITAL DISK RECORDER Eigen | LMB |
| Apr 1, 1994 | K935498 | 7500 DATA TOWER E-Systems, Inc. | LMB |
| Feb 18, 1994 | K931410 | NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM Novus Technologies, Inc. | LMB |
| Jan 28, 1994 | K934889 | OLYMPUS IMAGEMANAGER SYSTEM Olympus | LMB |
| Jan 25, 1994 | K934888 | OLYMPUS IMAGEMANAGERSYSTEM Olympus | LMB |
| Nov 19, 1993 | K926348 | SC1000 SCAN CONVERTER Perkins Mfg. Co. | LMB |
| Oct 20, 1992 | K923680 | ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM Minnetonka Medical | LMB |
| Jun 10, 1992 | K921275 | SONY LASER VIDEODISC RECORDING SYSTEM Sony Medical Systems | LMB |
| Mar 2, 1992 | K914728 | KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM Eastman Kodak Company | LMB |
| Dec 27, 1991 | K915094 | VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM Vortech Data, Inc. | LMB |
| Dec 18, 1991 | K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN Ausonics Pty , Ltd. | LMB |
| Nov 23, 1990 | K903806 | ANGIOTEC IMAGE MANAGEMENT SYSTEM Andros Analyzers, Inc. | LMB |
| Jul 2, 1990 | K901956 | DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) Eigen | LMB |
| Apr 10, 1990 | K901118 | OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM Adac Laboratories | LMB |
| Jun 15, 1989 | K891690 | KODAK EKTASCAN IMAGE MANAGER Eastman Kodak Company | LMB |
| May 11, 1989 | K885327 | PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM Philips Medical Systems North America, Inc. | LMB |
| May 5, 1989 | K891485 | ANGIOTEC FMX-2220 SYSTEM Andros Analyzers, Inc. | LMB |
| Mar 23, 1989 | K884990 | IMS-3 PICTURE ARCHIVING SYSTEM The Biomedical Engineering Center | LMB |
| Nov 23, 1988 | K884148 | DISKCAM DC 6001 Camtronics, Ltd. | LMB |
| Jun 28, 1988 | K882184 | HR-1000 W/SUFFIXES (B,C OR D) Eigen | LMB |
| Oct 30, 1987 | K873048 | KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET Eastman Kodak Company | LMB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.