Monaco RTP System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Monaco RTP System EUDAMED
- Device Name
- Monaco RTP System Software EUDAMED
- Model / Reference
- Monaco EUDAMEDMonaco 6.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340201500118 EUDAMED
- Basic UDI-DI
- 00858164002BUDI0000002H9 EUDAMED
- 510(k) Number
- K223233 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
- EMDN Code
- Z11010401,Z11010492 EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Monaco RTP System is a Radiation Therapy Treatment Planning System (product code MUJ), designed to calculate precise radiation dose distributions for cancer treatment. It employs advanced algorithms, including the Monte Carlo method, to optimize treatment planning and enhance accuracy in delivering therapeutic radiation doses to targeted areas while minimizing exposure to surrounding healthy tissue.
This system is intended for use in radiation oncology departments and is supplied as a software-based solution integrated with compatible linear accelerators or treatment planning workstations. It operates under FDA 510(k) clearance (K223233) and MDR authorization, classified as a Class II medical device under regulatory number 892.5050. The device is non-sterile, reusable, and requires proper calibration and maintenance in accordance with manufacturer guidelines.
Frequently asked questions
What is the primary purpose of the Monaco RTP System in a clinical setting?
The Monaco RTP System is designed to calculate precise radiation dose distributions for cancer treatment. It uses advanced algorithms, including the Monte Carlo method, to optimize treatment planning, ensuring accurate delivery of therapeutic radiation to targeted tumor areas while minimizing exposure to surrounding healthy tissue. This makes it essential for radiation oncology departments focused on improving treatment accuracy.
How is the Monaco RTP System supplied and what type of environment is it intended for?
The Monaco RTP System is supplied as a software-based solution, meaning it is integrated with compatible linear accelerators or treatment planning workstations rather than being a standalone physical device. It is intended for use exclusively in radiation oncology departments, where it can be utilized alongside existing equipment to enhance treatment planning precision.
Is the Monaco RTP System single-use or reusable, and what maintenance requirements does it have?
The Monaco RTP System is a reusable device, not single-use. Since it is software-based and integrated with hardware, it requires proper calibration and maintenance in accordance with the manufacturer’s guidelines to ensure continued accuracy and reliability in radiation dose calculations.
What regulatory pathways has the Monaco RTP System undergone, and what classification does it hold?
The Monaco RTP System has obtained FDA 510(k) clearance (K223233) and MDR authorization, classifying it as a Class II medical device under regulatory number 892.5050. This means it has undergone rigorous review to demonstrate substantial equivalence to existing devices and meets stringent safety and performance standards for radiation therapy planning systems.
Does the Monaco RTP System require special handling or storage conditions?
As a non-sterile, reusable software-based system, the Monaco RTP System does not require sterile packaging or specialized storage conditions beyond standard IT infrastructure for software deployment. However, the hardware components it integrates with (such as linear accelerators or workstations) should be stored and maintained according to manufacturer specifications to ensure optimal performance and longevity.
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: Monaco RTP System - Elekta Solutions Ab | FDA Reference, Monaco RTP System - Elekta Solutions Ab | FDA Reference, K213787 - Monaco RTP System | FDA 510(k) | Elekta Solutions AB, Monaco Rtp System (K202789) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223233 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Solutions Ab
Sources (2)
- FDA 510(k) K223233 24 fields · synced Sep 18, 2026
- EUDAMED c734a074-80d9-4098-9b2e-d1aab68ac818 61 fields · synced Jul 14, 2026