DeepHealth
Medical device makerAI in United StatesAI, part of RadNetAI. FDA records under 3 spellings of its name, each linked to the record.
- 510(k) clearances: 10
- AI-enabled devices: 9
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 15, 2026 | Saige-DxK253825 · QDQ | 510(k) clearances |
| Jun 15, 2026 | Saige-DxK253825 · Radiology | AI-enabled devices |
| May 21, 2026 | BACK254131 · QIH | 510(k) clearances |
| May 21, 2026 | BACK254131 · Radiology | AI-enabled devices |
| Aug 11, 2025 | Saige-DxK251873 · QDQ | 510(k) clearances |
| Aug 11, 2025 | Saige-DxK251873 · Radiology | AI-enabled devices |
| Jun 5, 2025 | TechLiveK243703 · LLZ | 510(k) clearances |
| Dec 19, 2024 | Saige-Density (2.5.0)K243705 · QIH | 510(k) clearances |
| Dec 19, 2024 | Saige-Dx (3.1.0)K243688 · QDQ | 510(k) clearances |
| Dec 19, 2024 | Saige-Density (2.5.0)K243705 · Radiology | AI-enabled devices |
| Dec 19, 2024 | Saige-Dx (3.1.0)K243688 · Radiology | AI-enabled devices |
| Nov 18, 2024 | Saige-DxK241747 · QDQ | 510(k) clearances |
| Nov 18, 2024 | Saige-DxK241747 · Radiology | AI-enabled devices |
| Dec 16, 2022 | Saige-DensityK222275 · QIH | 510(k) clearances |
| Dec 16, 2022 | Saige-DensityK222275 · Radiology | AI-enabled devices |
| May 12, 2022 | Saige-DxK220105 · Radiology | AI-enabled devices |
Names and Identifiers
- Appears as
- Website
- radnet.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