Clearance Summary
ANT-X System received FDA 510(k) clearance under submission number K230185, sponsored by Ndr Medical Technology Pte. , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-06-01.
- Submission: K230185
- Applicant / Sponsor: Ndr Medical Technology Pte. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2023-06-01
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.