FDA 510(k) Application Details - K222895

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K222895
Device Name	System, Tomography, Computed, Emission
Applicant	GE Medical Systems SCS 283, rue de la Miniere Buc 78530 FR Other 510(k) Applications for this Company
Contact	Tong Zhao 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	09/23/2022
Decision Date	11/22/2022
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