LMD · System, Digital Image Communications, Radiological
Radiology · 21 CFR 892.2020 · Class 1
Overview
| Product Code | LMD |
|---|---|
| Device Name | System, Digital Image Communications, Radiological |
| Regulation | 21 CFR 892.2020 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.
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 142)
Showing 20 most recent of 142 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | Terarecon,Inc. | May 26, 2000 | SESE |
| K992698 | STENTOR, PAGEVIEW | Stentor, Inc. | Oct 25, 1999 | SESE |
| K992426 | RAYPAX WEB CLINICAL SYSTEM | Samsung Sds Co., Ltd. | Oct 13, 1999 | SESE |
| K992352 | ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 | Inteleradiology, Inc. | Sep 29, 1999 | SESE |
| K991537 | SAMSUNG RAYPAX SYSTEM | Samsung Sds Co., Ltd. | Jul 6, 1999 | SESE |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Surgical Navigation Technologies, Inc. | Jan 12, 1999 | SESE |
| K974707 | IMAGEQUEST | Visual Med, Inc. | Jul 31, 1998 | SESE |
| K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW | Eastman Kodak Company | Jun 18, 1998 | SESE |
| K980918 | JPACS | Philips Medical Systems (Cleveland), Inc. | Jun 3, 1998 | SESE |
| K974882 | DOWNSCAN LT | Merlin Engineering Works, Inc. | May 22, 1998 | SESE |
| K980684 | VR NETSERVE | I.S.G. Technologies, Inc. | May 6, 1998 | SESE |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | Barco NV Display Systems | Apr 9, 1998 | SESE |
| K980241 | NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE | Netco Communications Corp. | Mar 17, 1998 | SESE |
| K980220 | IISYS PACS SYSTEM | Sterling Diagnostic Imaging, Inc. | Feb 13, 1998 | SESE |
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | Dejarnette Research Systems | Jan 29, 1998 | SESE |
| K974255 | CD-R STATION AND VRS-2000 | Electromed Intl., Ltd. | Jan 27, 1998 | SESE |
| K974107 | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) | Eastman Kodak Company | Jan 21, 1998 | SESE |
| K974102 | MILTRA IMAGING INC., IMAGE VAULT | Mitra Imaging, Inc. | Jan 20, 1998 | SESE |
| K973805 | IMAGEACCESS SYSTEM | Storcomm, Inc. | Jan 2, 1998 | SESE |
| K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | Barco NV Display Systems | Jan 2, 1998 | SESE |
Top Applicants
- Dejarnette Research Systems — 7 clearances
- Eastman Kodak Company — 7 clearances
- Vortech Data, Inc. — 5 clearances
- Image Data Corp. — 4 clearances
- Merlin Engineering Works, Inc. — 4 clearances
