ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT— 510(k) K863710

Name: FDA 510(k) clearance K863710
Creator: U.S. Food and Drug Administration
Published: 1986-10-14

Substantially Equivalent

Ausonics Pty , Ltd.

FDA 510(k) clearance K863710 for ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT, Substantially Equivalent on 1986-10-14. 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: 1986-09-23
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

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