ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101— 510(k) K023373

Name: FDA 510(k) clearance K023373
Creator: U.S. Food and Drug Administration
Published: 2003-01-03

Substantially Equivalent

Gvi Technology Partners

FDA 510(k) clearance K023373 for ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101, Substantially Equivalent on 2003-01-03. 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: 2002-10-08
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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