Class Class II
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794)
Description
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS by Cefla S.C., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223794
Clearance Date2023-01-17
Clearance TypeSpecial
Product CodeOAS
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223794
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. hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026 |
Trace the full predicate network for K223794
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.