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510(k) K973421

IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} by Dejarnette Research Systems — Product Code LMD

K973421 is an FDA 510(k) premarket notification submitted by Dejarnette Research Systems for the device "IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}". The FDA issued a decision of Substantially Equivalent on Dec 5, 1997. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Dejarnette Research Systems has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 5, 1997
Date Received
Sep 10, 1997
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 Dejarnette Research Systems

  • K974130 — VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE (Jan 29, 1998)
  • K973422 — LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) (Oct 28, 1997)
  • K963861 — LASERSHARE PRINT SPOOLER AND/OR SOFTWARE (Dec 18, 1996)
  • K963628 — IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE (Nov 7, 1996)
  • K963592 — IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOL (Nov 7, 1996)
  • K963594 — IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGI (Nov 7, 1996)
  • K925793 — TELESHARE 910 (Feb 26, 1993)
  • K925284 — IMAGESSSHARE 910 (Jan 21, 1993)

Other clearances for product code LMD

  • K994329 — IIVS INTEGRATED IMAGE VIEWING STATION (May 26, 2000)
  • K992698 — STENTOR, PAGEVIEW (Oct 25, 1999)
  • K992426 — RAYPAX WEB CLINICAL SYSTEM (Oct 13, 1999)
  • K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (Sep 29, 1999)
  • K991537 — SAMSUNG RAYPAX SYSTEM (Jul 6, 1999)
  • K984000 — STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (Jan 12, 1999)
  • K974707 — IMAGEQUEST (Jul 31, 1998)
  • K981053 — KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (Jun 18, 1998)
  • K980918 — JPACS (Jun 3, 1998)
  • K974882 — DOWNSCAN LT (May 22, 1998)

FDA data resources