Class Class II
Halcyon, Ethos Radiotherapy System (K222941)
Description
Halcyon, Ethos Radiotherapy System by Varian Medical Systems, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222941
Clearance Date2023-01-17
Clearance TypeTraditional
Product CodeIYE
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222941
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. Halcyon, Ethos Radiotherapy System (K222941) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos... | Varian Medical Systems, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 |
Trace the full predicate network for K222941
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.