FDA 510(k) Application Details - K212067

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K212067
Device Name	System, X-Ray, Tomography, Computed
Applicant	GE Healthcare Japan Corporation 7-127, 4-Chome, Asahigaoka, Hino 191-8503 JP Other 510(k) Applications for this Company
Contact	Katelyn Rowley 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	07/02/2021
Decision Date	09/17/2021
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