Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list TheraPanacea with 7 510(k) clearances and 7 AI-enabled devices. The most recent is a 510(k) clearance dated Dec 23, 2025: ART-Plan+ (v3.1.0).
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 23, 2025 | ART-Plan+ (v3.1.0)K253091 · MUJ | 510(k) clearances |
| Dec 23, 2025 | ART-Plan+ (v3.1.0)K253091 · Radiology | AI-enabled devices |
| Feb 25, 2025 | ART-Plan+ (v.3.0.0)K242822 · MUJ | 510(k) clearances |
| Feb 25, 2025 | ART-Plan+ (v.3.0.0)K242822 · Radiology | AI-enabled devices |
| Apr 22, 2024 | ART-Plan (v.2.2.0)K234068 · MUJ | 510(k) clearances |
| Apr 22, 2024 | ART-Plan (v.2.2.0)K234068 · Radiology | AI-enabled devices |
| Dec 22, 2023 | ART-PlanK232479 · MUJ | 510(k) clearances |
| Dec 22, 2023 | ART-PlanK232479 · Radiology | AI-enabled devices |
| Apr 19, 2023 | ART-PlanK230023 · QKB | 510(k) clearances |
| Apr 19, 2023 | ART-PlanK230023 · Radiology | AI-enabled devices |
| Jun 17, 2022 | ART-PLANK220813 · QKB | 510(k) clearances |
| Jun 17, 2022 | ART-PLANK220813 · Radiology | AI-enabled devices |
| Jan 14, 2021 | ART-PlanK202700 · QKB | 510(k) clearances |
| Jan 14, 2021 | ART-PlanK202700 · 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
