TRIDENT Mobile Fluoroscopy System
FDA 510(k) K233380 · Dornier Medtech America
510(k) numberK233380
Submission
- Device name
- TRIDENT Mobile Fluoroscopy System
- Applicant
- Dornier Medtech America
Kennesaw, GA, US - Received
- October 2, 2023
- Decision date
- June 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was TRIDENT Mobile Fluoroscopy System cleared by the FDA?
TRIDENT Mobile Fluoroscopy System (K233380) received a 510(k) decision of Substantially Equivalent on June 26, 2024, 268 days after the submission was received.
What is the product code of K233380?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.