X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC— 510(k) K770693

Name: FDA 510(k) clearance K770693
Creator: U.S. Food and Drug Administration
Published: 1977-08-03

Substantially Equivalent

Xonics Medical Systems, Inc.

FDA 510(k) clearance K770693 for X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC, Substantially Equivalent on 1977-08-03. Applicant: Xonics Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Xonics Medical Systems, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1977-04-13
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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