FDA 510(k) Application Details - K222222

Device Classification Name	More FDA Info for this Device
510(K) Number	K222222
Device Name	Artemis, Artemis TPO, Artemis MX
Applicant	Eigen 13300 Grass Valley Ave Ste A Grass Valley, CA 95945 US Other 510(k) Applications for this Company
Contact	William Mandel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2022
Decision Date	10/12/2023
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