DXX
- Product code
- DXX
- Device name
- System, Catheter Control, Steerable
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1290
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 34
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262744 | 2026-08-27 | Stereotaxis, Inc. | GenesisX RMN | |
| K251792 | 2025-11-06 | Stereotaxis, Inc. | Stereotaxis GenesisX RMN with Navigant Workstation | |
| K243789 | 2025-09-04 | Microbot Medical , Ltd. | LIBERTY Endovascular Robotic System (LIBERTYOS) | FDA |
Official FDA classification page: DXX
Classification and pathway per current FDA publications. Data from openFDA (CC0).