FDA 510(k) Application Details - K240793

Device Classification Name	More FDA Info for this Device
510(K) Number	K240793
Device Name	MSKai
Applicant	MSKai 6075 Poplar Suite 221 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Wade Lloyd Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2024
Decision Date	12/16/2024
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