Cleared Traditional

K233380 - TRIDENT Mobile Fluoroscopy System
(FDA 510(k) Clearance)

K233380 · Dornier Medtech America · Radiology

Jun 2024

Decision

268d

Days

Class 2

Risk

K233380 is an FDA 510(k) clearance for the TRIDENT Mobile Fluoroscopy System, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Dornier Medtech America (Kennesaw, US). The FDA issued a Cleared decision on June 26, 2024, 268 days after receiving the submission on October 2, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K233380 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2023
Decision Date	June 26, 2024
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF