MUJ · System, Planning, Radiation Therapy Treatment
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | MUJ |
|---|---|
| Device Name | System, Planning, Radiation Therapy Treatment |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 252)
Showing 20 most recent of 252 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | Mar 18, 2026 | SESE |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | Feb 19, 2026 | SESE |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | Feb 19, 2026 | SESE |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | Dec 23, 2025 | SESE |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | Dec 22, 2025 | SESE |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | Dec 19, 2025 | SESE |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | Nov 20, 2025 | SESE |
| K250064 | Dose+ (1.0) | Mvision AI OY | Sep 4, 2025 | SESE |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | Jun 17, 2025 | SESE |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | Apr 17, 2025 | SESE |
| K242748 | Oncospace | Oncospace, Inc. | Apr 11, 2025 | SESE |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | Apr 4, 2025 | SESE |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | Feb 25, 2025 | SESE |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | Dec 13, 2024 | SESE |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | Dec 11, 2024 | SESE |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | Dec 4, 2024 | SESE |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | Oct 23, 2024 | SESE |
| K241876 | Vitesse (5.0) | Varian Medical Systems | Oct 23, 2024 | SESE |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | Aug 30, 2024 | SESE |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | May 17, 2024 | SESE |
Top Applicants
- Varian Medical Systems, Inc. — 26 clearances
- RaySearch Laboratories AB (PUBL) — 15 clearances
- Siemens Medical Solutions USA, Inc. — 13 clearances
- Brainlab AG — 11 clearances
- Computerized Medical Systems, Inc. — 9 clearances
