FDA 510(k) Application Details - K210931

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K210931
Device Name	System, Image Processing, Radiological
Applicant	Dyad Medical, Inc. 215 Brighton Avenue, Suite 203 Boston, MA 02134 US Other 510(k) Applications for this Company
Contact	Ronny Shalev Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2021
Decision Date	12/17/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review