510(k) K992352

ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 by Inteleradiology, Inc. — Product Code LMD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 29, 1999
Date Received: July 14, 1999
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Digital Image Communications, Radiological
Device Class: Class I
Regulation Number: 892.2020
Review Panel: RA
Submission Type

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. 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.

Other clearances for product code LMD

K994329 — IIVS INTEGRATED IMAGE VIEWING STATION (May 26, 2000)
K992698 — STENTOR, PAGEVIEW (October 25, 1999)
K992426 — RAYPAX WEB CLINICAL SYSTEM (October 13, 1999)
K991537 — SAMSUNG RAYPAX SYSTEM (July 6, 1999)
K984000 — STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (January 12, 1999)
K974707 — IMAGEQUEST (July 31, 1998)
K981053 — KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (June 18, 1998)
K980918 — JPACS (June 3, 1998)
K974882 — DOWNSCAN LT (May 22, 1998)
K980684 — VR NETSERVE (May 6, 1998)