LMB · Device, Digital Image Storage, Radiological
Radiology · 21 CFR 892.2010 · Class 1
Overview
| Product Code | LMB |
|---|---|
| Device Name | Device, Digital Image Storage, Radiological |
| Regulation | 21 CFR 892.2010 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE | Samsung Sds Co., Ltd. | Sep 13, 1999 | SESE |
| K984405 | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | Feb 8, 1999 | SESE |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | Sectra-Imtec AB | Oct 29, 1998 | SESE |
| K980243 | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | Parameter Developments, Inc. | Apr 3, 1998 | SESE |
| K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | O Tech, Inc. | Dec 2, 1997 | SESE |
| K973413 | ID. STORE (RELEASE 2.0) | I.S.G. Technologies, Inc. | Nov 25, 1997 | SESE |
| K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) | Eastman Kodak Company | Sep 11, 1997 | SESE |
| K971848 | TDK MEDICAL GRADE CD-R | Tdk Electronics Corporation of America | Aug 15, 1997 | SESE |
| K971451 | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | Jun 26, 1997 | SESE |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Biosound, Inc. | Mar 31, 1997 | SESE |
| K964803 | UNIVISION ECHOCARDIOLOGY SYSTEM | Network Concepts, Inc. | Feb 11, 1997 | SESE |
| K964274 | WRITESTAR, AND VIEWSTAR | Comview Corp. | Jan 10, 1997 | SESE |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Sectra-Imtec AB | Oct 25, 1996 | SESE |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | Jul 3, 1996 | SESE |
| K961160 | UPACS VERSION 1.7 | Base Ten Systems, Inc. | Jun 11, 1996 | SESE |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | Kodak Health Imaging Systems, Inc. | Jun 7, 1996 | SESE |
| K960941 | UPACS | Base Ten Systems, Inc. | Jun 3, 1996 | SESE |
| K951942 | LAST IMAGE HOLD | Insight Systems | Apr 8, 1996 | SESE |
| K955237 | TIGERSCAN/TIGERVIEW | Tau Corp. | Apr 4, 1996 | SESE |
| K960326 | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM | Fujifilm Medical System U.S.A., Inc. | Mar 7, 1996 | SESE |
Top Applicants
- Eastman Kodak Company — 4 clearances
- Eigen — 3 clearances
- Camtronics, Ltd. — 3 clearances
- Sony Medical Systems — 2 clearances
- Sectra-Imtec AB — 2 clearances
