Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list DiA Imaging Analysis with 10 510(k) clearances and 10 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 17, 2025: LVivo Software Application.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 17, 2025 | LVivo Software ApplicationK243862 · QIH | 510(k) clearances |
| Mar 17, 2025 | LVivo Software ApplicationK243862 · Radiology | AI-enabled devices |
| Mar 6, 2025 | LVivo SeamlessK243331 · QIH | 510(k) clearances |
| Mar 6, 2025 | LVivo SeamlessK243331 · Radiology | AI-enabled devices |
| Mar 3, 2025 | LVivo Software ApplicationK243235 · QIH | 510(k) clearances |
| Mar 3, 2025 | LVivo Software ApplicationK243235 · Radiology | AI-enabled devices |
| Oct 4, 2024 | LVivo Software ApplicationK240553 · QIH | 510(k) clearances |
| Oct 4, 2024 | LVivo Software ApplicationK240553 · Radiology | AI-enabled devices |
| May 24, 2024 | LVivo IQSK240769 · QIH | 510(k) clearances |
| May 24, 2024 | LVivo IQSK240769 · Radiology | AI-enabled devices |
| Feb 1, 2023 | LVivo IQSK222970 · QIH | 510(k) clearances |
| Feb 1, 2023 | LVivo IQSK222970 · Radiology | AI-enabled devices |
| Dec 9, 2021 | LVivo SeamlessK212466 · QIH | 510(k) clearances |
| Dec 9, 2021 | LVivo SeamlessK212466 · Radiology | AI-enabled devices |
| Feb 5, 2021 | LVivo Software ApplicationK210053 · QIH | 510(k) clearances |
| Feb 5, 2021 | LVivo Software ApplicationK210053 · Radiology | AI-enabled devices |
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
