FDA 510(k) Application Details - K202992

Device Classification Name	More FDA Info for this Device
510(K) Number	K202992
Device Name	BriefCase, RIB Fractures Triage (RibFx)
Applicant	Aidoc Medical, Ltd. 3 Aminaday St. Tel-Aviv 6706703 IL Other 510(k) Applications for this Company
Contact	Nimrod Epstein Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2020
Decision Date	04/14/2021
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