Class Class II
Xeleris V Processing and Review System (K221680)
Description
Xeleris V Processing and Review System by Ge Healthcare, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221680
Clearance Date2023-03-01
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221680
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. Xeleris V Processing and Review System (K221680) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020 |
| K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243605 | Aurora | Ge Medical Systems Israel, Function... | 2025 |
| K241350 | Clarify DL | Ge Medical Systems Israel, Function... | 2025 |
Trace the full predicate network for K221680
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.