FDA 510(k) Application Details - K220271

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K220271
Device Name	System, X-Ray, Stationary
Applicant	NanoRay Biotech Co., Ltd 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City 114 TW Other 510(k) Applications for this Company
Contact	Alice Chen Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2022
Decision Date	04/29/2022
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