Class Class II
CT Scanner TSX-501R/1 V11.1 (K243398)
Description
CT Scanner TSX-501R/1 V11.1 by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243398
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243398
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. CT Scanner TSX-501R/1 V11.1 (K243398) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | 2023 |
| K211591 | NAEOTOM Alpha, Scan&GO | Siemens Medical Solutions USA, Inc. | 2021 |
Trace the full predicate network for K243398
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.