Company profile

Sonio

Sonio has 5 AI-enabled medical devices on the FDA list. The first decision was on July 25, 2023 and the most recent on June 4, 2026 (Sonio Suspect). Its most common review panel is Radiology (5 devices).

5AI devices

2023First decision

2026Latest decision

1Specialties

Per year

2023202420252026

Sonio AI devices per year: 2023 1, 2024 1, 2025 1, 2026 2

By specialty

Radiology5

Related guides

Top radiology devices

Timeline

June 4, 2026 · 510(k) K261519Sonio Suspect · Radiology · POK
March 16, 2026 · 510(k) K252433Sonio Detect (v3) · Radiology · IYN
February 21, 2025 · 510(k) K243614Sonio Suspect · Radiology · POK
April 26, 2024 · 510(k) K240406Sonio Detect · Radiology · IYN
July 25, 2023 · 510(k) K230365Sonio Detect · Radiology · IYN