DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)— 510(k) K000976

Name: FDA 510(k) clearance K000976
Creator: U.S. Food and Drug Administration
Published: 2000-06-01

Substantially Equivalent

Instrumentarium Imaging, Inc.

FDA 510(k) clearance K000976 for DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM), Substantially Equivalent on 2000-06-01. Applicant: Instrumentarium Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentarium Imaging, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2000-03-27
Decision date: 2000-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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