MINXRAY 500M MAMMOGRAPHIC SYSTEM— 510(k) K854510

Substantially Equivalent

Minxray, Inc.

FDA 510(k) clearance K854510 for MINXRAY 500M MAMMOGRAPHIC SYSTEM, Substantially Equivalent on 1986-01-01. Applicant: Minxray, Inc.. Device class: 2.

Clearance details

Applicant: Minxray, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1985-11-12
Decision date: 1986-01-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evanston, IL, 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.