FDA 510(k) Application Details - K161009

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K161009
Device Name	System, X-Ray, Tomography, Computed
Applicant	TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI OTAWARA-SHI 324-8550 JP Other 510(k) Applications for this Company
Contact	PAUL BIGGINS Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2016
Decision Date	07/22/2016
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