DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM— 510(k) K003473

Name: FDA 510(k) clearance K003473
Creator: U.S. Food and Drug Administration
Published: 2000-11-28

Substantially Equivalent

Elscintec Systems , Ltd.

FDA 510(k) clearance K003473 for DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM, Substantially Equivalent on 2000-11-28. Applicant: Elscintec Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Elscintec Systems , Ltd.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2000-11-08
Decision date: 2000-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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