FDA 510(k) Application Details - K231731

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K231731
Device Name	System, Tomography, Computed, Emission
Applicant	McGovern Medical School 6431 Fannin Street, MSB 4.256 Houston, TX 77030 US Other 510(k) Applications for this Company
Contact	K. Lance Gould Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2023
Decision Date	08/21/2023
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