FDA 510(k) Application Details - K180393

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K180393
Device Name	System, X-Ray, Tomography, Computed
Applicant	Mobius Imaging, LLC 2 Shaker Road Shirley, MA 01464 US Other 510(k) Applications for this Company
Contact	Norma LeMay 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	02/13/2018
Decision Date	03/15/2018
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