NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER— 510(k) K090553

Name: FDA 510(k) clearance K090553
Creator: U.S. Food and Drug Administration
Published: 2009-03-31

Substantially Equivalent

Naviscan, Inc.

FDA 510(k) clearance K090553 for NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER, Substantially Equivalent on 2009-03-31. Applicant: Naviscan, Inc.. Device class: 2.

Clearance details

Applicant: Naviscan, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2009-03-02
Decision date: 2009-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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