CLARITY PET— 510(k) K032866

Substantially Equivalent

Shared P.E.T. Imaging, LLC

FDA 510(k) clearance K032866 for CLARITY PET, Substantially Equivalent on 2003-12-12. Applicant: Shared P.E.T. Imaging, LLC. Device class: 2.

Clearance details

Applicant: Shared P.E.T. Imaging, LLC
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2003-09-15
Decision date: 2003-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.