FDA 510(k) Application Details - K203720

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K203720
Device Name	System, X-Ray, Tomography, Computed
Applicant	ISYS Medizintechnik GMBH Bergwerksweg 21 Kitzbuehel 6370 AT Other 510(k) Applications for this Company
Contact	Michael Vogele 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	12/21/2020
Decision Date	06/22/2021
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