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.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list UltraSight Ltd. with 3 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Dec 18, 2025: PVAD IQ Software.
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.
| Dec 18, 2025 | PVAD IQ SoftwareK252235 · QIH | 510(k) clearances |
| Dec 18, 2025 | PVAD IQ SoftwareK252235 · Radiology | AI-enabled devices |
| Dec 17, 2025 | UltraSight GuidanceK251416 · QJU | 510(k) clearances |
| Dec 17, 2025 | UltraSight GuidanceK251416 · Radiology | AI-enabled devices |
| Jul 24, 2023 | UltraSight AI GuidanceK223347 · QJU | 510(k) clearances |
| Jul 24, 2023 | UltraSight AI GuidanceK223347 · 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
