ART-Plan

FDA UDI

Class II (US FDA UDI)

by Therapanacea Sas

Identity

Trade Name: ART-Plan FDA UDI
Generic Name: Radiation therapy software FDA UDI
Device Name: The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights. FDA UDI
Model / Reference: v.1.10.0 FDA UDI
Description: The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights. FDA UDI

Identifiers

Primary DI / UDI-DI: 03770019940006 FDA UDI
FDA Product Code: QKB FDA UDI
LLZ FDA UDI
MUJ FDA UDI
GMDN Term: Radiation therapy software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation therapy software

ART-Plan by Therapanacea Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Therapanacea Sas

Sources (1)

FDA UDI 208d980c-e36c-4e7e-b86a-7cd220714260 34 fields · synced Jun 8, 2026