FDA 510(k) Application Details - K213725

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K213725
Device Name	System, X-Ray, Tomography, Computed
Applicant	GE Medical Systems SCS 283, rue de la Miniere Buc 78530 FR Other 510(k) Applications for this Company
Contact	Yonghui Han Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2021
Decision Date	03/11/2022
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