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510(k) K181343

HeartSee Cardiac P.E.T. Processing Software by Bracco Diagnostics, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2018
Date Received
May 21, 2018
Clearance Type
Traditional
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 Bracco Diagnostics, Inc.

  • K243881 — HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Corona (March 3, 2025)

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