FDA 510(k) Application Details - K243810

Device Classification Name	More FDA Info for this Device
510(K) Number	K243810
Device Name	TraumaCad Neo (1.1)
Applicant	Brainlab Ltd. 35 Efal Street Petach-Tikva 4951132 IL Other 510(k) Applications for this Company
Contact	Veronika Kravtsov 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	12/11/2024
Decision Date	06/04/2025
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