FDA 510(k) Application Details - K212470

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K212470
Device Name	System, Image Processing, Radiological
Applicant	Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore 088443 SG Other 510(k) Applications for this Company
Contact	Devika Dutt Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2021
Decision Date	10/20/2021
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