Class Class II
Aurora (K243605)
Description
Aurora by Ge Medical Systems Israel, Functional Imaging, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243605
Clearance Date2025-01-17
Clearance TypeTraditional
Product CodeKPS
Regulation Number892.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243605
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. Aurora (K243605) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221680 | Xeleris V Processing and Review System | GE Healthcare | 2023 |
| K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 |
| K173816 | NM/CT 850, NM/CT 860 | GE Healthcare | 2018 |
| K093514 | DISCOVERY MODEL NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251153 | Aurora | Ge Medical Systems Israel | 2025 |
Trace the full predicate network for K243605
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.