FDA 510(k) Application Details - K220034

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K220034
Device Name	System, Image Processing, Radiological
Applicant	In-Med Prognostics L3C 4918 September Street San Diego, CA 92110 US Other 510(k) Applications for this Company
Contact	Latha Poonamalle Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2022
Decision Date	09/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review