MAMMOGRAPHIC X-RAY SYSTEM ATHENA— 510(k) K880531

Name: FDA 510(k) clearance K880531
Creator: U.S. Food and Drug Administration
Published: 1988-05-02

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K880531 for MAMMOGRAPHIC X-RAY SYSTEM ATHENA, Substantially Equivalent on 1988-05-02. Applicant: Fischer Imaging Corp.. Device class: 2.

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1988-02-09
Decision date: 1988-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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