Class Class II
NEONA 1.5T MRI System (K222259)
Description
NEONA 1.5T MRI System by Time Medical Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222259
Clearance Date2023-02-21
Clearance TypeAbbreviated
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222259
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. NEONA 1.5T MRI System (K222259) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183621 | EMMA 1.5T MRI System | Time Medical Limited | 2019 |
Trace the full predicate network for K222259
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.