C-PET PLUS IMAGING SYSTEM— 510(k) K042839

Name: FDA 510(k) clearance K042839
Creator: U.S. Food and Drug Administration
Published: 2004-10-29

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K042839 for C-PET PLUS IMAGING SYSTEM, Substantially Equivalent on 2004-10-29. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-10-14
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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