FDA 510(k) Application Details - K222746

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K222746
Device Name	Analyzer,Medical Image
Applicant	Overjet, Inc. 560 Harrison St., Unit 403 Boston, MA 02118 US Other 510(k) Applications for this Company
Contact	Adam Odeh Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2022
Decision Date	03/27/2023
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