MAMMOSPOT 3 AND MAMMOSPOT 8— 510(k) K904517

Name: FDA 510(k) clearance K904517
Creator: U.S. Food and Drug Administration
Published: 1990-11-15

Substantially Equivalent

American Mammographics, Inc.

FDA 510(k) clearance K904517 for MAMMOSPOT 3 AND MAMMOSPOT 8, Substantially Equivalent on 1990-11-15. Applicant: American Mammographics, Inc.. Device class: 2.

Clearance details

Applicant: American Mammographics, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1990-10-03
Decision date: 1990-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chattanooga, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.