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

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..

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.