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510(k) K981053

KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW by Eastman Kodak Company — Product Code LMD

K981053 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW". The FDA issued a decision of Substantially Equivalent on June 18, 1998. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1998
Date Received
March 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 Eastman Kodak Company

  • K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (March 31, 2006)
  • K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE (March 16, 2006)
  • K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM (February 8, 2006)
  • K060055 — KODAK PACS (February 7, 2006)
  • K053347 — KODAK CARESTREAM PACS (January 4, 2006)
  • K051483 — KODAK DIRECTVIEW DR SYSTEM DETECTOR (June 21, 2005)
  • K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (June 1, 2005)
  • K042159 — KODAK COLOR MEDICAL IMAGER 1000 (September 24, 2004)
  • K042158 — KODAK MEDICAL IMAGER 300 (September 24, 2004)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)

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)
  • K980918 — JPACS (June 3, 1998)
  • K974882 — DOWNSCAN LT (May 22, 1998)
  • K980684 — VR NETSERVE (May 6, 1998)

FDA data resources