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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 the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America. It received FDA 510(k) clearance on 2024-06-26 under 510(k) 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. The listed applicant is Dornier Medtech America. The 510(k) number is K233380.

When did TRIDENT Mobile Fluoroscopy System receive FDA 510(k) clearance?

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

Who is the listed applicant for TRIDENT Mobile Fluoroscopy System?

The FDA 510(k) record lists Dornier Medtech America as the applicant. This does not by itself establish the device manufacturer.

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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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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