FDA 510(k) Application Details - K230130

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K230130
Device Name	System, X-Ray, Tomography, Computed
Applicant	ISYS Medizintechnik GMBH Bergwerksweg 21, Salzburg Kitzbuehel 6370 AT Other 510(k) Applications for this Company
Contact	Pedro Costa 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	01/17/2023
Decision Date	10/10/2023
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