FDA 510(k) Application Details - K231576

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K231576
Device Name	System, Tomography, Computed, Emission
Applicant	Combinostics Oy HatanpΣΣn valtatie 24 Tampere 33100 FI Other 510(k) Applications for this Company
Contact	Thurfjell Lennart 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	05/31/2023
Decision Date	09/14/2023
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