MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM— 510(k) K941353

Name: FDA 510(k) clearance K941353
Creator: U.S. Food and Drug Administration
Published: 1995-03-31

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K941353 for MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM, Substantially Equivalent on 1995-03-31. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1994-03-21
Decision date: 1995-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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