FDA 510(k) Application Details - K193351

Device Classification Name	More FDA Info for this Device
510(K) Number	K193351
Device Name	NinesAI
Applicant	Nines, Inc. 329 Alma St. Palo Alto, CA 94301 US Other 510(k) Applications for this Company
Contact	Russell Stewart Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2019
Decision Date	04/21/2020
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