CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE— 510(k) K112474

Name: FDA 510(k) clearance K112474
Creator: U.S. Food and Drug Administration
Published: 2011-09-23

Substantially Equivalent

Cedars-Sinai Medical Center

FDA 510(k) clearance K112474 for CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE, Substantially Equivalent on 2011-09-23. Applicant: Cedars-Sinai Medical Center. Device class: 2.

Clearance details

Applicant: Cedars-Sinai Medical Center
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2011-08-26
Decision date: 2011-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, 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.