Class Class II
OmniTom Elite with PCD (K250928)
Description
OmniTom Elite with PCD by Neurologica Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250928
Clearance Date2025-09-08
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250928
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. OmniTom Elite with PCD (K250928) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026 |
Trace the full predicate network for K250928
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.