Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list RAY Co., Ltd. with 24 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Apr 9, 2026: RCT800.
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 |
|---|---|---|
| Apr 9, 2026 | RCT800K260462 · OAS | 510(k) clearances |
| Nov 25, 2025 | RCT700K251798 · OAS | 510(k) clearances |
| May 21, 2025 | SMARTDentK251109 · LLZ | 510(k) clearances |
| Mar 12, 2025 | RCT600K243903 · OAS | 510(k) clearances |
| May 16, 2024 | RAYDENT SWK233625 · PNN | 510(k) clearances |
| May 16, 2024 | RAYDENT SWK233625 · Dental | AI-enabled devices |
| Apr 18, 2024 | RAYSCAN a-ExpertK232325 · MUH | 510(k) clearances |
| Aug 31, 2023 | RAYSCAN a-Expert3DK232287 · OAS | 510(k) clearances |
| Apr 11, 2023 | RCT800K230753 · OAS | 510(k) clearances |
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
