Siemens Healthineers AG - FDA 510(k) Cleared Devices
Recent clearances: Syngo Carbon Space (VA4), MAGNETOM Flow.Elite, LungMaps
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthineers AG Radiology ✕
6 devices
Cleared
Sep 29, 2026
Syngo Carbon Space (VA4)
Radiology
29d
Cleared
Jul 31, 2026
MAGNETOM Flow.Elite
Radiology
137d
Cleared
Jun 15, 2026
LungMaps
Radiology
206d
Cleared
Jan 15, 2026
BIOGRAPH One
Radiology
118d
Cleared
Nov 20, 2025
syngo.MR Applications (VB80)
Radiology
23d
Cleared
Oct 24, 2025
Syngo Carbon Clinicals (VA41)
Radiology
203d