Catalogue number 11330002, listed by Siemens Healthineers AG, Germany, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for System Somatom X.ceed | Listed by | Siemens Healthineers AG, Germany |
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K253574 |
| Record published | 2026-04-07 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 50 °C; Handling environment humidity 10 to 90 % RH; Storage environment humidity 10 to 90 % RH; Handling environment temperature -20 to 50 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling 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.