FDA 510(k) Application Details - K231955

Device Classification Name	More FDA Info for this Device
510(K) Number	K231955
Device Name	aprevo« Digital Segmentation
Applicant	Carlsmed, Inc. 1800 Aston Ave. Suite 100 San Diego, CA 92008 US Other 510(k) Applications for this Company
Contact	Karen Liu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2023
Decision Date	11/03/2023
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