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510(k) K112474

CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE by Cedars-Sinai Medical Center — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
August 26, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Cedars-Sinai Medical Center

  • K172609 — CSMC Cardiac Suite (November 3, 2017)
  • K141652 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (July 22, 2014)
  • K123433 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (February 26, 2013)
  • K100714 — CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 (April 1, 2011)

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