Class Class II
CoLumboX (K250367)
Description
CoLumboX by Smart Soft Healthcare AD, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250367
Clearance Date2025-05-28
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250367
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. CoLumboX (K250367) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241211 | CoLumbo | Smart Soft Healthcare | 2024 |
| K231668 | Spine CAMP™ (1.1) | Medical Metrics, Inc. | 2023 |
Trace the full predicate network for K250367
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.