FDA 510(k) Application Details - K203517

Device Classification Name	More FDA Info for this Device
510(K) Number	K203517
Device Name	Saige-Q
Applicant	DeepHealth, Inc. 1000 Massachusetts Ave Cambridge, MA 02138 US Other 510(k) Applications for this Company
Contact	A. Gregory Sorensen 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	11/30/2020
Decision Date	04/16/2021
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