Siemens Healthcare

FDA Regulatory Profile

Siemens Healthcare appears in FDA public data with 0 recalls, 32 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 16, 2026.

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253264myAblation Guide (VC10A)June 16, 2026
K252548AI-Rad Companion Organs RTApril 10, 2026
K253689syngo Dynamics (VA41F)April 10, 2026
K253057AI-Rad Companion Brain MRJanuary 22, 2026
K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM LumDecember 19, 2025
K252608AI-Rad Companion Prostate MRSeptember 9, 2025
K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileJune 16, 2025
K242551syngo Dynamics (Version VA41D)April 3, 2025
K242745AI-Rad Companion Organs RTMarch 27, 2025
K241770Prostate MR AI (VA10A)March 5, 2025
K240796myAblation Guide (VB80A)August 6, 2024
K240294Syngo Carbon Enterprise Access (VA40A)May 23, 2024
K233753AI-Rad Companion (Pulmonary)March 21, 2024
K232744syngo Virtual Cockpit (VB10A)December 21, 2023
K232856Syngo Carbon ClinicalsDecember 1, 2023
K231157syngo.CT Lung CAD (Version VD30)July 19, 2023
K230561Syngo Carbon Space VA30AMarch 21, 2023
K230196syngo.via View&GO VA40AFebruary 13, 2023
K221501syngo.via View&GOOctober 14, 2022
K213713AI-Rad Companion (Pulmonary)August 11, 2022