ROTATING GAMMA SYSTEM INFINI (INFINI)— 510(k) K102533

Name: FDA 510(k) clearance K102533
Creator: U.S. Food and Drug Administration
Published: 2011-03-22

Substantially Equivalent

Masep Medical Science & Tech.Development (Shenzhen

FDA 510(k) clearance K102533 for ROTATING GAMMA SYSTEM INFINI (INFINI), Substantially Equivalent on 2011-03-22. Applicant: Masep Medical Science & Tech.Development (Shenzhen. Device class: 2.

Clearance details

Applicant: Masep Medical Science & Tech.Development (Shenzhen
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2010-09-03
Decision date: 2011-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.