Siemens Healthcare GmbH - FDA 510(k) Cleared Devices
Recent clearances: AI-Rad Companion Organs RT, syngo Dynamics (VA41F), AI-Rad Companion Brain MR
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare GmbH Radiology ✕
30 devices
Cleared
Apr 10, 2026
AI-Rad Companion Organs RT
Radiology
240d
Cleared
Apr 10, 2026
syngo Dynamics (VA41F)
Radiology
140d
Cleared
Jan 22, 2026
AI-Rad Companion Brain MR
Radiology
122d
Cleared
Dec 19, 2025
MAGNETOM Sola
Radiology
105d
Cleared
Sep 09, 2025
AI-Rad Companion Prostate MR
Radiology
22d
Cleared
Jun 16, 2025
MAGNETOM Avanto Fit
Radiology
122d
Cleared
Apr 03, 2025
syngo Dynamics (Version VA41D)
Radiology
219d
Cleared
Mar 27, 2025
AI-Rad Companion Organs RT
Radiology
197d
Cleared
Mar 05, 2025
Prostate MR AI (VA10A)
Radiology
258d
Cleared
Aug 06, 2024
myAblation Guide (VB80A)
Radiology
137d
Cleared
May 23, 2024
Syngo Carbon Enterprise Access (VA40A)
Radiology
112d
Cleared
Mar 21, 2024
AI-Rad Companion (Pulmonary)
Radiology
120d