MAMMOGRAPH— 510(k) K010792

Substantially Equivalent

Digitec Medical Service Corp.

FDA 510(k) clearance K010792 for MAMMOGRAPH, Substantially Equivalent on 2001-04-03. Applicant: Digitec Medical Service Corp.. Device class: 2.

Clearance details

Applicant: Digitec Medical Service Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2001-03-16
Decision date: 2001-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, GA, 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.