ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM— 510(k) K051402

Name: FDA 510(k) clearance K051402
Creator: U.S. Food and Drug Administration
Published: 2005-06-13

Substantially Equivalent

Gvi Technology Partners

FDA 510(k) clearance K051402 for ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM, Substantially Equivalent on 2005-06-13. Applicant: Gvi Technology Partners. Device class: 1.

Clearance details

Applicant: Gvi Technology Partners
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2005-05-31
Decision date: 2005-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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