LUMAGEM MOLECULAR BREAST IMAGING SYSTEM— 510(k) K111791

Name: FDA 510(k) clearance K111791
Creator: U.S. Food and Drug Administration
Published: 2011-09-23

Substantially Equivalent

Gamma Medica-Ideas Incorporated

FDA 510(k) clearance K111791 for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM, Substantially Equivalent on 2011-09-23. Applicant: Gamma Medica-Ideas Incorporated. Device class: 1.

Clearance details

Applicant: Gamma Medica-Ideas Incorporated
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2011-06-27
Decision date: 2011-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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