Patient-Matched 3d Printed Radiation Therapy Accessory (Ultrasint TPU)
This patient-matched radiation therapy accessory shapes the dose near the body surface during external-beam treatment. It is designed to address the skin-sparing effect of high-energy…
This patient-matched radiation therapy accessory shapes the dose near the body surface during external-beam treatment. It is designed to address the skin-sparing effect of high-energy photons and electrons by providing a customised accessory fitted to the patient and treatment plan.
Radiation therapy planning data is used to generate a three-dimensional design and printable STL file. The accessory is manufactured with an HP Jet Fusion 5200 system using the validated Ultrasint TPU01 thermoplastic polyurethane powder.
Listed Item
Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.
Design Verification
Trained radiation therapy professionals verify the proposed accessory against the treatment planning system before printing or ordering it. The printed accessory implements that design and is separate from the planning software.
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 | Adaptiiv Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Manufacturer |
| 510(k) | K213438 |
| Record published | 2022-08-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Case of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | 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 |
| Monaco | Elekta Solutions AB | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260308 | 2026-02-19 |
| K243057 | 2024-10-23 |
| K241318 | 2024-08-30 |
| K213438 | 2022-01-19 |
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.