FDA 510(k) Application Details - K191688

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K191688
Device Name	System, Image Processing, Radiological
Applicant	Subtle Medical, Inc. 883 Santa Cruz Ave, Suite 205 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Ajit Shankaranarayanan 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	06/24/2019
Decision Date	09/16/2019
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