FDA 510(k) Application Details - K171738

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K171738
Device Name	System, X-Ray, Tomography, Computed
Applicant	Hitachi Healthcare Americas Corporation 1959 Summit Commerce Park Twinsburg, OH 44087 US Other 510(k) Applications for this Company
Contact	Doug Thistlethwaite 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	06/12/2017
Decision Date	08/18/2017
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