Class Class II
ANT-X System (K230185)
Description
ANT-X System by Ndr Medical Technology Pte. , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230185
Clearance Date2023-06-01
Clearance TypeAbbreviated
Product CodeOWB
Regulation Number892.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230185
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ANT-X System (K230185) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 |
| K131433 | ISYS 1 (U.S),ACCESSORY, NON-STERILE | Isys Medizintechnik GmbH | 2014 |
Trace the full predicate network for K230185
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.