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510(k) K940423

NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE by Advanced Technology Laboratories, Inc. — Product Code LMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1994
Date Received
January 31, 1994
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.

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  • K992470 — ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM (August 23, 1999)
  • K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (June 18, 1999)
  • K961459 — LEVEL 10 HDI (March 26, 1997)
  • K935009 — PEGASUS (October 11, 1994)
  • K905248 — NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (February 28, 1991)
  • K903603 — ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) (February 26, 1991)
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Other clearances for product code LMD

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  • 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)