Company profile

Siemens Healthineers AG

Siemens Healthineers AG has 3 AI-enabled medical devices on the FDA list. The first decision was on October 24, 2025 and the most recent on June 15, 2026 (LungMaps). Its most common review panel is Radiology (3 devices).

3AI devices

2025First decision

2026Latest decision

1Specialties

Per year

20252026

Siemens Healthineers AG AI devices per year: 2025 1, 2026 2

By specialty

Radiology3

Related guides

Top radiology devices

Timeline

June 15, 2026 · 510(k) K253690LungMaps · Radiology · QIH
January 15, 2026 · 510(k) K253023BIOGRAPH One · Radiology · OUO
October 24, 2025 · 510(k) K251059Syngo Carbon Clinicals (VA41) · Radiology · QIH