FDA 510(k) Application Details - K193152

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K193152
Device Name	System, Tomography, Computed, Emission
Applicant	Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm 11251 SE Other 510(k) Applications for this Company
Contact	Joakim Arwidson Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2019
Decision Date	02/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review