FDA 510(k) Application Details - K234030

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K234030
Device Name	System, X-Ray, Tomography, Computed
Applicant	Clear Guide Medical 3600 Clipper Mill Road, Suite 400 Baltimore, MD 21211 US Other 510(k) Applications for this Company
Contact	Alican Demir 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	12/20/2023
Decision Date	01/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review