FDA 510(k) Application Details - K231761

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K231761
Device Name	System, X-Ray, Stationary
Applicant	Skanray Technologies Limited Plot#15-17, Hebbal Industrial Area Mysore 570016 IN Other 510(k) Applications for this Company
Contact	Vasundhara R 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	06/16/2023
Decision Date	10/27/2023
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