Sonio
Medical device makerAI in FranceAI, part of Samsung ElectronicsAI. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 5
- AI-enabled devices: 5
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 4, 2026 | Sonio SuspectK261519 · POK | 510(k) clearances |
| Jun 4, 2026 | Sonio SuspectK261519 · Radiology | AI-enabled devices |
| Mar 16, 2026 | Sonio Detect (v3)K252433 · IYN | 510(k) clearances |
| Mar 16, 2026 | Sonio Detect (v3)K252433 · Radiology | AI-enabled devices |
| Feb 21, 2025 | Sonio SuspectK243614 · POK | 510(k) clearances |
| Feb 21, 2025 | Sonio SuspectK243614 · Radiology | AI-enabled devices |
| Apr 26, 2024 | Sonio DetectK240406 · IYN | 510(k) clearances |
| Apr 26, 2024 | Sonio DetectK240406 · Radiology | AI-enabled devices |
| Jul 25, 2023 | Sonio DetectK230365 · IYN | 510(k) clearances |
| Jul 25, 2023 | Sonio DetectK230365 · Radiology | AI-enabled devices |
Names and Identifiers
- Appears as
- Website
- samsung.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built