POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM— 510(k) K001681

Name: FDA 510(k) clearance K001681
Creator: U.S. Food and Drug Administration
Published: 2000-08-25

Substantially Equivalent

Smv America

FDA 510(k) clearance K001681 for POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM, Substantially Equivalent on 2000-08-25. Applicant: Smv America. Device class: 2.

Clearance details

Applicant: Smv America
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2000-06-01
Decision date: 2000-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, 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.