Identifiers
- 510(k) Number
- K220813 FDA 510(k)
- FDA Product Code
- QKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ART-PLAN is a radiological image processing software for radiation therapy. It is an AI-based software platform designed to support radiotherapy treatment planning workflows by providing software modules for the preparation, assessment, and management of radiotherapy treatment planning activities using medical imaging data.
The device operates through a user account system and is supplied as a software platform. It is classified as a Class II device under FDA regulation 892.2050 with product code QKB and received FDA 510(k) clearance (K220813) on June 17, 2022, as substantially equivalent to a predicate device. The software is intended for use in radiology and radiotherapy settings by authorized users.
Frequently asked questions
What is ART-PLAN used for?
ART-PLAN is an AI-based software platform designed to support radiotherapy treatment planning workflows by providing modules for the preparation, assessment, and management of radiotherapy treatment planning activities using medical imaging data.
How is ART-PLAN supplied and accessed?
ART-PLAN is supplied as a software platform and operates through a user account system, intended for use by authorized users in radiology and radiotherapy settings.
Is ART-PLAN a single-use or reusable software device?
ART-PLAN is a reusable software platform accessed via user accounts, allowing ongoing use for radiotherapy treatment planning activities without physical consumption or single-use limitations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home | Therapanacea, ART-Plan - TheraPanacea, ART-Plan Overview Flyer | Therapanacea, ART-Plan™ - AI-powered radiotherapy - AEP
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220813 | Class II | Active |
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Manufacturer
- Manufacturer
- Therapanacea
Sources (1)
- FDA 510(k) K220813 24 fields · synced Sep 22, 2026