FDA 510(k) Application Details - K212519

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K212519
Device Name	Analyzer,Medical Image
Applicant	Overjet, Inc. 560 Harrison Ave, Unit 403 Boston, MA 02118 US Other 510(k) Applications for this Company
Contact	Wardah Inam 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	08/10/2021
Decision Date	05/10/2022
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