FDA 510(k) Application Details - K203187

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K203187
Device Name	System, X-Ray, Tomography, Computed
Applicant	CurveBeam, LLC 2800 Bronze Drive, Suite 110 Hatfield, PA 19044 US Other 510(k) Applications for this Company
Contact	Ryan Conlon 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	10/27/2020
Decision Date	11/18/2020
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	Y
Expedited Review