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510(k) K172609

CSMC Cardiac Suite by Cedars-Sinai Medical Center — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2017
Date Received
August 31, 2017
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

  • K141652 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (July 22, 2014)
  • K123433 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (February 26, 2013)
  • K112474 — CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE (September 23, 2011)
  • K100714 — CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 (April 1, 2011)

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