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510(k) K992426

RAYPAX WEB CLINICAL SYSTEM by Samsung Sds Co., Ltd. — Product Code LMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1999
Date Received
July 21, 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 by Samsung Sds Co., Ltd.

  • K002062 — SAMSUNG 10DR IMPLANT SYSTEM (November 9, 2000)
  • K992306 — SAMSUNG RAYPAX DISPLAY WORKSTATION (September 22, 1999)
  • K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE (September 13, 1999)
  • K992112 — SAMSUNG RAYPAX FILM DIGITIZER (September 9, 1999)
  • K991537 — SAMSUNG RAYPAX SYSTEM (July 6, 1999)

Other clearances for product code LMD

  • K994329 — IIVS INTEGRATED IMAGE VIEWING STATION (May 26, 2000)
  • K992698 — STENTOR, PAGEVIEW (October 25, 1999)
  • K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (September 29, 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)