Class Class II
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819)
Description
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222819
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222819
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 Serve (TSX-307A/1) V1.2 with AiCE-i (K222819) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021 |
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | 2023 |
Trace the full predicate network for K222819
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.