FDA 510(k) Application Details - K240827

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K240827
Device Name	System, Tomography, Computed, Emission
Applicant	Shimadzu Corporation Medical Systems Division 1, Nishinokyo-Kuwabaracho, Nakagyoku Kyoto 604-8511 JP Other 510(k) Applications for this Company
Contact	Koichi Kataoka 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	03/26/2024
Decision Date	05/24/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review