Monaco RTP System
FDA 510(k) K223233 · Elekta Solutions AB
510(k) numberK223233
Submission
- Device name
- Monaco RTP System
- Applicant
- Elekta Solutions AB
Stockholm, SE - Received
- October 19, 2022
- Decision date
- February 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 510(k) | Device | Decision |
|---|---|---|
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | 08/05/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | 02/19/2026SE |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…IYE · Traditional | 01/15/2026SE |
| K251363 | ProKnow DSLLZ · Traditional | 10/08/2025SE |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife®…IWB · Traditional | 07/02/2025SE |
| K232854 | Leksell GammaPlan (LGP)IWB · Traditional | 02/08/2024SE |
| K223229 | MOSAIQ® OIS (Oncology Information System)IYE · Traditional | 02/23/2023SE |
| K223209 | Elekta UnityIYE · Traditional | 02/23/2023SE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…IWB · Traditional | 10/26/2022SE |
| K213787 | Monaco RTP SystemMUJ · Traditional | 05/17/2022SE |
Questions and answers
When was Monaco RTP System cleared by the FDA?
Monaco RTP System (K223233) received a 510(k) decision of Substantially Equivalent on February 23, 2023, 127 days after the submission was received.
What is the product code of K223233?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.