FDA applicant
Therapanacea Sas
FDA records 7 decisions for Therapanacea Sas (Paris, FR) from 2021 to 2025: 7 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and QKB (Radiological Image Processing Software For…). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Therapanacea”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Therapanacea Sas’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Therapanacea Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report