Company profile

Siemens Healthcare GmbH

Siemens Healthcare GmbH has 15 AI-enabled medical devices on the FDA list. The first decision was on March 31, 2021 and the most recent on April 10, 2026 (AI-Rad Companion Organs RT). Its most common review panel is Radiology (15 devices).

15AI devices

2021First decision

2026Latest decision

1Specialties

Per year

202120222023202420252026

Siemens Healthcare GmbH AI devices per year: 2021 1, 2022 2, 2023 2, 2024 2, 2025 5, 2026 3

By specialty

Radiology15

Related guides

Top radiology devices

Timeline

April 10, 2026 · 510(k) K252548AI-Rad Companion Organs RT · Radiology · QKB
April 10, 2026 · 510(k) K253689syngo Dynamics (VA41F) · Radiology · QIH
January 22, 2026 · 510(k) K253057AI-Rad Companion Brain MR · Radiology · QIH
December 19, 2025 · 510(k) K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise · Radiology · LNH
June 16, 2025 · 510(k) K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile · Radiology · LNH
April 3, 2025 · 510(k) K242551syngo Dynamics (Version VA41D) · Radiology · QIH
March 27, 2025 · 510(k) K242745AI-Rad Companion Organs RT · Radiology · QKB
March 5, 2025 · 510(k) K241770Prostate MR AI (VA10A) · Radiology · QDQ
May 23, 2024 · 510(k) K240294Syngo Carbon Enterprise Access (VA40A) · Radiology · LLZ
March 21, 2024 · 510(k) K233753AI-Rad Companion (Pulmonary) · Radiology · JAK
December 1, 2023 · 510(k) K232856Syngo Carbon Clinicals · Radiology · QIH
July 19, 2023 · 510(k) K231157syngo.CT Lung CAD (Version VD30) · Radiology · OEB
August 11, 2022 · 510(k) K213713AI-Rad Companion (Pulmonary) · Radiology · JAK
April 15, 2022 · 510(k) K213706AI-Rad Companion Brain MR · Radiology · QIH
March 31, 2021 · 510(k) K203258syngo.CT Lung CAD · Radiology · OEB