TISSUE-EQUIVALENT BREAST SIMULATOR— 510(k) K865100

Name: FDA 510(k) clearance K865100
Creator: U.S. Food and Drug Administration
Published: 1987-01-12

Substantially Equivalent

Computerized Imaging Reference Systems, Inc.

FDA 510(k) clearance K865100 for TISSUE-EQUIVALENT BREAST SIMULATOR, Substantially Equivalent on 1987-01-12. Applicant: Computerized Imaging Reference Systems, Inc.. Device class: 1.

Clearance details

Applicant: Computerized Imaging Reference Systems, Inc.
Product code: Code IXF
Device class: Class 1
Regulation: 21 CFR 892.1940
Advisory panel: Radiology
Date received: 1986-12-30
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norfolk, VA, US

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