FDA 510(k) Application Details - K191025

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K191025
Device Name	System, X-Ray, Mobile
Applicant	Carestream Health Inc. 150 Verona Street Rochester, NY 14608 US Other 510(k) Applications for this Company
Contact	Gina Maiolo Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2019
Decision Date	05/17/2019
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