FDA 510(k) Application Details - K241681

Device Classification Name	More FDA Info for this Device
510(K) Number	K241681
Device Name	Overjet Image Enhancement Assist
Applicant	Overjet Inc 50 Milk Street 16th Floor Boston, MA 02109 US Other 510(k) Applications for this Company
Contact	Deepthi Paknikar 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	06/11/2024
Decision Date	09/09/2024
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