AVIVA MAMMOGRAPHIC X-RAY SYSTEM— 510(k) K915748

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K915748 for AVIVA MAMMOGRAPHIC X-RAY SYSTEM, Substantially Equivalent on 1992-02-04. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1991-12-23
Decision date: 1992-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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