Class Class II
Limbus Contour (K241837)
Description
Limbus Contour by Limbus Ai, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241837
Clearance Date2024-10-09
Clearance TypeTraditional
Product CodeQKB
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241837
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. Limbus Contour (K241837) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230575 | Limbus Contour | Limbus Ai, Inc. | 2023 |
Trace the full predicate network for K241837
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.