FDA 510(k) Application Details - K243077

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K243077
Device Name	System, X-Ray, Angiographic
Applicant	Digital Surgery Systems, Inc. (d.b.a True Digital Surgery) 125 Cremona Dr Suite 110 Goleta, CA 93117 US Other 510(k) Applications for this Company
Contact	Lu Ju Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	06/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review