Allengers Medical Systems Limited - FDA 510(k) Cleared Devices
Recent clearances: Digital C-ARM with 3D, Wireless/ Wired X-Ray Flat Panel Detectors, Wireless/Wired X-Ray Flat Panel Detectors
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Allengers Medical Systems Limited Radiology ✕
8 devices
Cleared
Jun 05, 2026
Digital C-ARM with 3D
Radiology
249d
Cleared
Apr 18, 2025
Wireless/ Wired X-Ray Flat Panel Detectors
Radiology
135d
Cleared
Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
Radiology
59d
Cleared
Oct 26, 2022
DigiX FDX
Radiology
26d
Cleared
May 03, 2022
Cardiovascular Angiography System
Radiology
90d
Cleared
Jul 13, 2020
Digiscan FDX
Radiology
167d
Cleared
Oct 16, 2019
DigiX FDX
Radiology
30d
Cleared
Mar 03, 2017
DigiX FDX
Radiology
175d