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 13, 2026, FDA's public records list Pearl with 8 510(k) clearances and 8 AI-enabled devices. The most recent is a 510(k) clearance dated Nov 14, 2025: Second Opinion® Panoramic.
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 |
|---|---|---|
| Nov 14, 2025 | Second Opinion® PanoramicK250525 · MYN | 510(k) clearances |
| Nov 14, 2025 | Second Opinion® PanoramicK250525 · Radiology | AI-enabled devices |
| Jun 12, 2025 | Second Opinion® CSK243234 · MYN | 510(k) clearances |
| Jun 12, 2025 | Second Opinion® CSK243234 · Radiology | AI-enabled devices |
| May 23, 2025 | Second Opinion® 3DK243989 · QIH | 510(k) clearances |
| May 23, 2025 | Second Opinion® 3DK243989 · Radiology | AI-enabled devices |
| May 9, 2025 | Second Opinion® BLEK243230 · QIH | 510(k) clearances |
| May 9, 2025 | Second Opinion® BLEK243230 · Radiology | AI-enabled devices |
| May 5, 2025 | Second Opinion® PediatricK243893 · MYN | 510(k) clearances |
| May 5, 2025 | Second Opinion® PediatricK243893 · Radiology | AI-enabled devices |
| Apr 11, 2025 | Second Opinion Periapical Radiolucency ContoursK242600 · MYN | 510(k) clearances |
| Apr 11, 2025 | Second Opinion Periapical Radiolucency ContoursK242600 · Radiology | AI-enabled devices |
| Jan 16, 2025 | Second Opinion CCK242522 · MYN | 510(k) clearances |
| Jan 16, 2025 | Second Opinion CCK242522 · Radiology | AI-enabled devices |
| Mar 4, 2022 | Second OpinionK210365 · MYN | 510(k) clearances |
| Mar 4, 2022 | Second OpinionK210365 · 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
