FDA 510(k) Application Details - K182336

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K182336
Device Name	System, Tomography, Computed, Emission
Applicant	Subtle Medical, Inc. 880 Santa Cruz Ave, Suite 200 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Enhao Gong Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2018
Decision Date	11/30/2018
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