Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled 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 13, 2026, FDA's public records list Precision AI with 3 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Jan 12, 2026: Precision AI Surgical Planning System (PAI-SPS).
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 |
|---|---|---|
| Jan 12, 2026 | Precision AI Surgical Planning System (PAI-SPS)K251558 · QHE | 510(k) clearances |
| Jan 12, 2026 | Precision AI Surgical Planning System (PAI-SPS)K251558 · Orthopedic | AI-enabled devices |
| Jan 21, 2025 | Precision AI Surgical Planning System (PAI-SPS)K243955 · QHE | 510(k) clearances |
| Jan 21, 2025 | Precision AI Surgical Planning System (PAI-SPS)K243955 · Orthopedic | AI-enabled devices |
| Aug 5, 2024 | Precision AI Surgical Planning System (PAI-SPS)K233992 · QHE | 510(k) clearances |
| Aug 5, 2024 | Precision AI Surgical Planning System (PAI-SPS)K233992 · Orthopedic | 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
