Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335)
Description
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243335
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. Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction ... | Canon Medical Systems Corporation | 2024 |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction P... | Canon Medical Systems Corporation | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Recon... | Canon Medical Systems Corporation | 2025 |
Trace the full predicate network for K243335
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.