FDA.report

510(k) K233380

Device
TRIDENT Mobile Fluoroscopy System
Applicant
Dornier Medtech America
510(k) number
K233380
Product code
JAA
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-26
Date received
2023-10-02
Regulation
892.1650
Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
John Hoffer
Address
1155 Roberts Blvd. Kennesaw GA US 30144 30144

FDA Registration Numbers

Source Documents

510(k) summary PDF

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