Catalogue number 10830856, listed by Siemens Healthcare Limited, Canada, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product 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.
Record
Regulatory record for syngo VSim | Listed by | Siemens Healthcare Limited, Canada |
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K151887 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | serial number |
| Storage | Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment temperature -20 to 50 °C; Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
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.