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510(k) K052537

CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 by American Medical Sales, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2005
Date Received
September 15, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by American Medical Sales, Inc.

  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K922079 — ROTOLUX, SELECTOLUX, SHUTTERVUE (June 16, 1992)

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