FDA 510(k) Application Details - K243688

Device Classification Name	More FDA Info for this Device
510(K) Number	K243688
Device Name	Saige-Dx (3.1.0)
Applicant	DeepHealth, Inc. 212 Elm Street Somerville, MA 02144 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	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review