FDA 510(k) Application Details - K213691

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K213691
Device Name	Cabinet,X-Ray System
Applicant	Cirdan Imaging Ltd The Green, Tullynacross Rd, Lambeg Lisburn BT27 5SR GB Other 510(k) Applications for this Company
Contact	Paul Matthews Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	MWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2021
Decision Date	12/22/2021
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	Y
Expedited Review