FDA 510(k) Application Details - K222275

Device Classification Name	More FDA Info for this Device
510(K) Number	K222275
Device Name	Saige-Density
Applicant	DeepHealth, Inc. 1000 Massachusetts Avenue Cambridge, MA 01238 US Other 510(k) Applications for this Company
Contact	B. Nathan Hunt 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	07/29/2022
Decision Date	12/16/2022
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