Class Class II
TrueBeam, TrueBeam STx, Edge, VitalBeam (K223839)
Description
TrueBeam, TrueBeam STx, Edge, VitalBeam by Varian Medical Systems, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223839
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeIYE
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223839
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. TrueBeam, TrueBeam STx, Edge, VitalBeam (K223839) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2022 |
Trace the full predicate network for K223839
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.