FDA 510(k) Application Details - K232698

Device Classification Name	More FDA Info for this Device
510(K) Number	K232698
Device Name	NemoScan
Applicant	Software Nemotec S.L. Av. Juan Caramuel, 1 Leganes 28919 ES Other 510(k) Applications for this Company
Contact	Miguel Del Moral 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	09/05/2023
Decision Date	01/18/2024
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