Monaco
Monaco is a radiation therapy planning system for patients with prescriptions for external-beam radiation therapy. It calculates photon, electron and proton treatment plans and displays…
Monaco is a radiation therapy planning system for patients with prescriptions for external-beam radiation therapy. It calculates photon, electron and proton treatment plans and displays dose distributions within the patient.
The filing lists functions for contouring, image manipulation, simulation, image fusion and plan optimization. It also includes quality assurance and plan review in its workflow.
Planning Workflow
Monaco 6.2 is described as an update to the previously cleared system. Its listed workflow includes image manipulation, simulation, image fusion, quality assurance and plan review.
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Elekta Solutions AB, Sweden |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K223233 |
| Record published | 2019-10-17 |
| Record revised | 2025-06-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Monaco | In distribution | |
| 6.2 | In distribution | |
| Monaco | In distribution | |
| Monaco 6.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RayStation | RaySearch Laboratories AB (publ) | 29 |
| System, Planning, Radiation Therapy Treatment | Nucletron B.V. | 17 |
| Panther TPS | Prowess, Inc. | 14 |
| RayCare | RaySearch Laboratories AB (publ) | 12 |
| Accuray Precision® Treatment Planning System | Accuray Incorporated | 7 |
| Monaco | Elekta Inc. | 7 |
| Eclipse Treatment Planning System for External Beam Radiation Therapy | Varian Medical Systems, Inc | 6 |
| syngo.via RT Image Suite | Siemens Healthcare Limited | 5 |
| Eclipse Treatment Planning System | Varian Medical Systems, Inc | 5 |
| Corvus 09 | Best Nomos | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
| Philips | Philips Medical Systems (Cleveland), Inc. | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252002 | 2026-02-19 |
| K223233 | 2023-02-23 |
| K213787 | 2022-05-17 |
| K202789 | 2021-02-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.