Class Class II
Mobius3D (4.1) (K250099)
Description
Mobius3D (4.1) by Varian Medical Systems, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250099
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeIYE
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250099
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. Mobius3D (4.1) (K250099) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203669 | Mobius3D | Varian Medical Systems, Inc. | 2021 |
Trace the full predicate network for K250099
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.