DXG
- Product code
- DXG
- Device name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1435
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 177 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253092 | 2026-02-13 | Retia Medical Systems, Inc. | Argos Infinity (Rev. 1.0) | |
| K251275 | 2025-09-26 | Caretaker Medical | VitalStream ART Connect; VitalStream-Hemo | |
| K232048 | 2023-12-20 | Icu Medical | Cogent Hemodynamic Monitoring System; Cogent HMS |
Official FDA classification page: DXG
Classification and pathway per current FDA publications. Data from openFDA (CC0).