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510(k) K974255

CD-R STATION AND VRS-2000 by Electromed Intl., Ltd. — Product Code LMD

K974255 is an FDA 510(k) premarket notification submitted by Electromed Intl., Ltd. for the device "CD-R STATION AND VRS-2000". The FDA issued a decision of Substantially Equivalent on January 27, 1998. The device falls under product code LMD (System, Digital Image Communications, Radiological), a Class I device regulated under 21 CFR 892.2020. Electromed Intl., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1998
Date Received
November 13, 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 Electromed Intl., Ltd.

  • K003688 — VIEW READING STATION (January 22, 2001)
  • K000474 — VIEW NT (April 19, 2000)
  • K990759 — VIEW COM (April 15, 1999)
  • K971176 — VIEW ARCHIVING STATION (September 3, 1997)
  • K950694 — COMPACT-X (March 31, 1995)
  • K880050 — EDEC 60R (February 29, 1988)
  • K875341 — EDEC 60 R/F (February 1, 1988)
  • K875342 — EDEC 90C (January 29, 1988)
  • K871145 — EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR (March 31, 1987)
  • K870851 — EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR (March 20, 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