AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT— 510(k) K850173

Name: FDA 510(k) clearance K850173
Creator: U.S. Food and Drug Administration
Published: 1985-04-16

Substantially Equivalent

Ausonics Pty , Ltd.

FDA 510(k) clearance K850173 for AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT, Substantially Equivalent on 1985-04-16. Applicant: Ausonics Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Ausonics Pty , Ltd.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1985-01-16
Decision date: 1985-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

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