FDA 510(k)

ART-Plan+ (v3.1.0)

K-Number: K253091 · 2025-12-23

Decision Date2025-12-23

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ART-Plan+ (v3.1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea Sas. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253091. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART-Plan+ (v3.1.0)?

ART-Plan+ (v3.1.0) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Therapanacea Sas. The 510(k) number is K253091.

When did ART-Plan+ (v3.1.0) receive FDA 510(k) clearance?

ART-Plan+ (v3.1.0) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253091.

Who is the listed applicant for ART-Plan+ (v3.1.0)?

The FDA 510(k) record lists Therapanacea Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ART-Plan+ (v3.1.0)?

The FDA product code for ART-Plan+ (v3.1.0) is MUJ.

Other records listing Therapanacea Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242822ART-Plan+ (v.3.0.0)K234068ART-Plan (v.2.2.0)K230023ART-Plan

Related Devices (Code: MUJ)

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformai K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.