FDA 510(k) Application Details - K203610

Device Classification Name	More FDA Info for this Device
510(K) Number	K203610
Device Name	Automatic Anatomy Recognition (AAR)
Applicant	Quantitative Radiology Solutions, LLC 3675 Market Street, Suite 200 Philadelphia, PA 19104 US Other 510(k) Applications for this Company
Contact	Steve Owens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2020
Decision Date	04/20/2021
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