FDA 510(k) Application Details - K182727

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K182727
Device Name	Cabinet,X-Ray System
Applicant	Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 US Other 510(k) Applications for this Company
Contact	Meghan Wakeford Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	MWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	01/10/2019
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