FDA Product Code
FDA Product Code LMB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2010
510(k) Clearances — 55 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE | Samsung Sds Co., Ltd. | 1999-09-13 | Traditional | PDF ↗ |
| K984405 | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999-02-08 | Traditional | PDF ↗ |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | Sectra-Imtec AB | 1998-10-29 | Special | PDF ↗ |
| K980243 | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | Parameter Developments, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | O Tech, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K973413 | ID. STORE (RELEASE 2.0) | I.S.G. Technologies, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) | Eastman Kodak Company | 1997-09-11 | Traditional | PDF ↗ |
| K971848 | TDK MEDICAL GRADE CD-R | Tdk Electronics Corporation of America | 1997-08-15 | Traditional | PDF ↗ |
| K971451 | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Biosound, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K964803 | UNIVISION ECHOCARDIOLOGY SYSTEM | Network Concepts, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964274 | WRITESTAR, AND VIEWSTAR | Comview Corp. | 1997-01-10 | Traditional | PDF ↗ |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Sectra-Imtec AB | 1996-10-25 | Traditional | PDF ↗ |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | 1996-07-03 | Traditional | PDF ↗ |
| K961160 | UPACS VERSION 1.7 | Base Ten Systems, Inc. | 1996-06-11 | Traditional | PDF ↗ |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | Kodak Health Imaging Systems, Inc. | 1996-06-07 | Traditional | PDF ↗ |
| K960941 | UPACS | Base Ten Systems, Inc. | 1996-06-03 | Traditional | PDF ↗ |
| K951942 | LAST IMAGE HOLD | Insight Systems | 1996-04-08 | Traditional | PDF ↗ |
| K955237 | TIGERSCAN/TIGERVIEW | Tau Corp. | 1996-04-04 | Traditional | PDF ↗ |
| K960326 | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM | Fujifilm Medical System U.S.A., Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K952238 | VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) | Imaging Concepts, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K955184 | ACCULUPE | E For M Imaging Systems Div., Marquette Electronic | 1996-01-24 | Traditional | PDF ↗ |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-12-11 | Traditional | PDF ↗ |
| K950630 | WALLACH DIGITAL IMAGING SYSTEM | Wallach Surgical Devices, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K952888 | OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS | Olympus America, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K942558 | INSTACINE | Fidelity Medical, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K951141 | STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER | Star Technologies, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K945654 | NICOM DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-02-17 | Traditional | PDF ↗ |
| K933115 | DIGITAL DISK RECORDER | Eigen | 1994-04-07 | Traditional | PDF ↗ |
| K935498 | 7500 DATA TOWER | E-Systems, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K931410 | NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM | Novus Technologies, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K934889 | OLYMPUS IMAGEMANAGER SYSTEM | Olympus | 1994-01-28 | Traditional | PDF ↗ |
| K934888 | OLYMPUS IMAGEMANAGERSYSTEM | Olympus | 1994-01-25 | Traditional | PDF ↗ |
| K926348 | SC1000 SCAN CONVERTER | Perkins Mfg. Co. | 1993-11-19 | Traditional | PDF ↗ |
| K923680 | ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM | Minnetonka Medical | 1992-10-20 | Traditional | PDF ↗ |
| K921275 | SONY LASER VIDEODISC RECORDING SYSTEM | Sony Medical Systems | 1992-06-10 | Traditional | PDF ↗ |
| K914728 | KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM | Eastman Kodak Company | 1992-03-02 | Traditional | PDF ↗ |
| K915094 | VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM | Vortech Data, Inc. | 1991-12-27 | Traditional | PDF ↗ |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | Ausonics Pty , Ltd. | 1991-12-18 | Traditional | PDF ↗ |
| K903806 | ANGIOTEC IMAGE MANAGEMENT SYSTEM | Andros Analyzers, Inc. | 1990-11-23 | Traditional | PDF ↗ |
| K901956 | DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) | Eigen | 1990-07-02 | Traditional | PDF ↗ |
| K901118 | OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM | Adac Laboratories | 1990-04-10 | Traditional | PDF ↗ |
| K891690 | KODAK EKTASCAN IMAGE MANAGER | Eastman Kodak Company | 1989-06-15 | Traditional | PDF ↗ |
| K885327 | PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM | Philips Medical Systems North America, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K891485 | ANGIOTEC FMX-2220 SYSTEM | Andros Analyzers, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K884990 | IMS-3 PICTURE ARCHIVING SYSTEM | The Biomedical Engineering Center | 1989-03-23 | Traditional | PDF ↗ |
| K884148 | DISKCAM DC 6001 | Camtronics, Ltd. | 1988-11-23 | Traditional | PDF ↗ |
| K882184 | HR-1000 W/SUFFIXES (B,C OR D) | Eigen | 1988-06-28 | Traditional | PDF ↗ |
| K873048 | KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET | Eastman Kodak Company | 1987-10-30 | Traditional | PDF ↗ |
| K862842 | ADVANCED NUCLEAR COMPUTER | Advanced Nuclear Imaging Corp. | 1986-10-27 | Traditional | PDF ↗ |
| K863286 | ERS SYSTEM | General Electric Co. | 1986-10-27 | Traditional | PDF ↗ |
| K844132 | MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER | Sigma Teleproducts, Inc. | 1985-01-22 | Traditional | PDF ↗ |
| K843349 | ND3100 VIDEO IMAGER | Nuclear Data, Inc. | 1984-12-17 | Traditional | PDF ↗ |
| K833525 | CEMAX-1000 | Contour Medical Systems, Inc. | 1983-11-21 | Traditional | PDF ↗ |
Product code LMB · Class I · Radiology. Data: openFDA.