FDA 510(k) Application Details - K173478

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K173478
Device Name	System, X-Ray, Tomography, Computed
Applicant	Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 US Other 510(k) Applications for this Company
Contact	Victoria A. Wheeler 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	11/13/2017
Decision Date	01/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review