FDA 510(k) Application Details - K201092

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K201092
Device Name	System, X-Ray, Tomography, Computed
Applicant	Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove, WI 53122 US Other 510(k) Applications for this Company
Contact	Timothy Dondlinger 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	04/23/2020
Decision Date	10/29/2020
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