Class Class II
Aquilion ONE (TSX-308A/3) V1.5 (K242403)
Description
Aquilion ONE (TSX-308A/3) V1.5 by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242403
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242403
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. Aquilion ONE (TSX-308A/3) V1.5 (K242403) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging Syst... | Canon Medical Systems Corporation | 2022 |
Trace the full predicate network for K242403
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.