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510(k) K980684

VR NETSERVE by I.S.G. Technologies, Inc. — Product Code LMD

K980684 is an FDA 510(k) premarket notification submitted by I.S.G. Technologies, Inc. for the device "VR NETSERVE". The FDA issued a decision of Substantially Equivalent on May 6, 1998. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. I.S.G. Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1998
Date Received
February 23, 1998
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 I.S.G. Technologies, Inc.

  • K993673 — SNN FLUORO NAVIGATION SYSTEM (December 21, 1999)
  • K982570 — SNN SCOUT (January 13, 1999)
  • K973413 — ID. STORE (RELEASE 2.0) (November 25, 1997)
  • K970865 — ISG FAMILY OF VIEWING WANDS (June 4, 1997)
  • K960714 — ISG VIEWING WAND (May 29, 1996)
  • K941933 — ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW) (July 29, 1994)
  • K911783 — ALLEGRO VIEWING WAND (April 7, 1994)
  • K901679 — RESUBMITTED ISG 3DMV WORKSTATION (May 29, 1990)
  • K872150 — I.S.G. 3DMV WORKSTATION (August 12, 1987)

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)
  • 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)

FDA data resources