Class Class II
SIGNA Victor (K223439)
Description
SIGNA Victor by Ge Healthcare (Tianjin) Company Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223439
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223439
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. SIGNA Victor (K223439) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213603 | SIGNA Artist Evo | Ge Healthcare (Tianjin) Company Lim... | 2022 |
| K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Lim... | 2022 |
| K161567 | SIGNA Voyager | GE Healthcare | 2016 |
| K143251 | SIGNA Creator, SIGNA Explorer | Ge Healthcare (Ge Medical Systems, ... | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | 2025 |
| K233728 | SIGNA Champion | Ge Healthcare (Tianjin) Company Lim... | 2024 |
Trace the full predicate network for K223439
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.