FDA 510(k) Application Details - K240943

Device Classification Name	More FDA Info for this Device
510(K) Number	K240943
Device Name	LungVision
Applicant	BodyVision Medical Ltd. 7 Hamada St. Herzliya 4673341 IL Other 510(k) Applications for this Company
Contact	Benny Krauz 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	04/05/2024
Decision Date	10/01/2024
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