Class Class II
Auto Segmentation (K230082)
Description
Auto Segmentation by Ge Medical Systems, LLC, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230082
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeQKB
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230082
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. Auto Segmentation (K230082) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191928 | AccuContour | Xiamen Manteia Technology , Ltd. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242925 | MR Contour DL | GE Healthcare | 2025 |
Trace the full predicate network for K230082
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.