Data / Medical devices / France / Therapanacea

Therapanacea: FDA-registered device maker in Paris, France, 6 510(k) clearances

Name: Therapanacea FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Therapanacea is registered with the FDA (registration 3019834893) in Paris, France. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 25, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3019834893
Address: 7 bis boulevard Bourdon, Paris, France, 75004
Owner or operator: THERAPANACEA (10082087)
Roles: Manufacturer
First device listed: June 15, 2021
Registered through: 2026
Brand names listed: ART-Plan, ART-Plan v.1.10, ART-Plan v.1.10.1, ART-Plan v.2.1, ART-Plan v.2.2, ART-Plan+ v.3

Devices it lists

Device	Product code	Class	Role	Source
Radiological Image Processing Software For Radiation Therapy	QKB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 25, 2025	K242822	ART-Plan+ (v.3.0.0)	MUJ	Substantially Equivalent	Therapanacea Sas	accessdata.fda.gov
April 22, 2024	K234068	ART-Plan (v.2.2.0)	MUJ	Substantially Equivalent	Therapanacea Sas	accessdata.fda.gov
December 22, 2023	K232479	ART-Plan	MUJ	Substantially Equivalent	Therapanacea	accessdata.fda.gov
April 19, 2023	K230023	ART-Plan	QKB	Substantially Equivalent	Therapanacea Sas	accessdata.fda.gov
June 17, 2022	K220813	ART-PLAN	QKB	Substantially Equivalent	Therapanacea	accessdata.fda.gov
January 14, 2021	K202700	ART-Plan	QKB	Substantially Equivalent	Therapanacea	accessdata.fda.gov

Compare with other makers

Updated February 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.