RT Elements – Cranial SRS
Catalogue number 3.0, listed by Brainlab SE, Germany, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
7recalls on this code
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 | Brainlab SE, Germany |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K170750 |
| Record published | 2020-11-20 |
| Record revised | 2025-09-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.0 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Brainlab SE | 510(k) number | 2019-03-11 | Class II | Device Design | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default sys | US – 164 units; Outside the US – 333 | 2021-05-12 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-05 | Class II | Software design | Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. | 20 systems | 2017-08-21 |
| 2015-11-05 | Class II | Software design | Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0 | 48 systems | 2017-08-21 |
| 2014-11-19 | Class II | Software in the Use Environment | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. | 1412 systems total | 2018-03-28 |
| 2014-11-19 | Class II | Software in the Use Environment | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. | 1,412 systems total | 2018-03-28 |
| 2009-08-12 | Not classified | Other | Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may le | 230 units | 2011-03-16 |
| 2007-11-12 | Not classified | Component design/selection | Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in o | 23 units | 2009-07-24 |
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.