JAA · Class II · 21 CFR 892.1650

System, X-ray, Fluoroscopic, Image-intensified — FDA 510(k) Devices

2
Total
2
Cleared
23d
Avg days
2022
Since

List of System, X-ray, Fluoroscopic, Image-intensified devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Sep 12, 2023
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526
Canon Medical Systems Corporation
Radiology · 22d
Cleared Apr 18, 2022
Nautilus
K220871
Dornier Medtech America, Inc.
Radiology · 24d

How to use this database

This page lists all FDA 510(k) submissions for System, X-ray, Fluoroscopic, Image-intensified devices (product code JAA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →