K233380
- 510(k) number
- K233380
- Device name
- TRIDENT Mobile Fluoroscopy System
- Applicant
- Dornier Medtech America GA · US
- Product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Decision date
- 2024-06-26
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K233380.pdf
Official FDA record: K233380
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.