FDA 510(k) Application Details - K230611

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K230611
Device Name	System, Therapeutic, X-Ray
Applicant	Xstrahl Ltd Unit 2 Maybrook Industrial Estate Maybrook Road Brownhills WS8 7DG GB Other 510(k) Applications for this Company
Contact	Vineet Gupta Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2023
Decision Date	07/13/2023
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