FDA 510(k) Application Details - K230185

Device Classification Name	More FDA Info for this Device
510(K) Number	K230185
Device Name	ANT-X System
Applicant	NDR Medical Technology Pte. Ltd. 75 Ayer Rajah Crescent, #02-19 Singapore 139935 SG Other 510(k) Applications for this Company
Contact	Ng Ka Wei Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2023
Decision Date	06/01/2023
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