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FDA 510(k)

TRIDENT Mobile Fluoroscopy System

K-Number: K233380 · 2024-06-26

ApplicantDornier Medtech America
Decision Date2024-06-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRIDENT Mobile Fluoroscopy System is a medical device manufactured by Dornier Medtech America. It received FDA 510(k) clearance on 2024-06-26 under approval number K233380. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIDENT Mobile Fluoroscopy System?

TRIDENT Mobile Fluoroscopy System is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by Dornier Medtech America. The 510(k) number is K233380.

When was TRIDENT Mobile Fluoroscopy System approved by the FDA?

TRIDENT Mobile Fluoroscopy System received FDA 510(k) clearance on 2024-06-26, under approval number K233380.

What company makes TRIDENT Mobile Fluoroscopy System?

TRIDENT Mobile Fluoroscopy System is manufactured by Dornier Medtech America.

What is the FDA product code for TRIDENT Mobile Fluoroscopy System?

The FDA product code for TRIDENT Mobile Fluoroscopy System is JAA.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Dornier Medtech America

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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