Mapping and navigation
FDA decisions under product codes MTD, NLG, DXX, DQK, as the FDA record prints them, with the owning organisation and the Health Canada licence the registry pairs to the decision. 5 decisions.
| Device (FDA record) | Owner | FDA decision | Health Canada licence |
|---|---|---|---|
| Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc. | Not resolved | 510(k) 2025-12-04K252429 · JSON · ArrHub record | No licence as at 14 October 2026 |
| DeepRhythmAIMedicalgorithmics S.A. | Not resolved | 510(k) 2025-12-11K253141 · JSON · ArrHub record | No licence as at 14 October 2026 |
| OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc. | Not resolved | 510(k) 2026-03-13K253205 · JSON · ArrHub record | No licence as at 14 October 2026 |
| OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc. | Not resolved | 510(k) 2026-04-23K261012 · JSON · ArrHub record | No licence as at 14 October 2026 |
| GenesisX RMNStereotaxis, Inc. | Stereotaxis | 510(k) 2026-08-27K262744 · JSON · ArrHub record | No licence as at 14 October 2026 |
The registry and this page start at 1 January 2019.
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