FDA 510(k) Application Details - K213566

Device Classification Name	More FDA Info for this Device
510(K) Number	K213566
Device Name	ClearRead Xray Pneumothorax
Applicant	Riverain Technologies, Inc. 3020 South Tech Blvd. Miamisburg, OH 45342-4860 US Other 510(k) Applications for this Company
Contact	Jonathan Jackson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2021
Decision Date	03/10/2022
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