Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-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 14, 2026, FDA's public records list Viz.ai and its 1 subsidiaries with 12 AI-enabled devices and 10 510(k) clearances. The most recent is a 510(k) clearance dated Jun 10, 2025: Viz Subdural+, Viz SUBDURAL PLUS.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Viz.ai and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 10, 2025 | Viz Subdural+, Viz SUBDURAL PLUSK250354 · QIH | 510(k) clearances |
| Jun 10, 2025 | Viz Subdural+, Viz SUBDURAL PLUSK250354 · Radiology | AI-enabled devices |
| Feb 5, 2024 | Viz HDS, Viz Volume Plus, Viz ICH+K232363 · QIH | 510(k) clearances |
| Feb 5, 2024 | Viz HDS, Viz Volume Plus, Viz ICH+K232363 · Radiology | AI-enabled devices |
| Aug 3, 2023 | Viz HCMDEN230003 · QXO | 510(k) clearances |
| Aug 3, 2023 | Viz HCMDEN230003 · Cardiovascular | AI-enabled devices |
| Mar 17, 2023 | Viz AAAK223443 · QFM | 510(k) clearances |
| Mar 17, 2023 | Viz AAAK223443 · Radiology | AI-enabled devices |
| Oct 21, 2022 | Viz LVO ContaCTK223042 · QAS | 510(k) clearances |
| Oct 21, 2022 | Viz LVO ContaCTK223042 · Radiology | AI-enabled devices |
| Aug 29, 2022 | Viz RV/LVK221100 · QIH | 510(k) clearances |
| Aug 29, 2022 | Viz RV/LVK221100 · Radiology | AI-enabled devices |
| Jul 25, 2022 | Viz SDHK220439 · QAS | 510(k) clearances |
| Jul 25, 2022 | Viz SDHK220439 · Radiology | AI-enabled devices |
| Feb 18, 2022 | Viz ANEURYSM, Viz ANXK213319 · QFM | 510(k) clearances |
| Feb 18, 2022 | Viz ANEURYSM, Viz ANXK213319 · 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
