FDA 510(k) Application Details - K210344

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K210344
Device Name	System, Image Processing, Radiological
Applicant	PrecisionOS Technology Inc. 500-319 West Hastings Street Vancouver V6B 1H6 CA Other 510(k) Applications for this Company
Contact	Danny Goel 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	02/05/2021
Decision Date	11/10/2021
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