The PRORAD 2FC system is a Digital radiographic X-ray intended to be used to Perform X-ray Examinations for diagnostic procedures. The PRORAD 2FC system holds the X-ray tube in Tube Column.…
The PRORAD 2FC system is a Digital radiographic X-ray intended to be used to Perform X-ray Examinations for diagnostic procedures. The PRORAD 2FC system holds the X-ray tube in Tube Column. Tube Column consists Longitudinal Floor rail system with longitudinal travel (1100mm) and telescopic Tube with transversal travel (Minimum of 100 mm). The Tube holder system is fixed to vertical carriage which travels in vertical distance (Minimum of 1420 mm). The Tube holder system also rotates the tube about transversal axis for a range of ± 135 Degree. The vertical travel is both automatic and Manual, Longitudinal, Tube rotation and Telescopic travel are manual only. All the braking mechanism of the Tube Carrier system is Electromagnetic. The PRORAD 2FC system holds the Detector in Bucky column. Bucky column also have similar set of movements except that Bucky column does not have transversal movement. Bucky holder travels (1100 mm) in longitudinal axis on longitudinal rails. Vertical axis travel 1330 mm of Bucky holder system is both manual and automatic. Longitudinal and Bucky rotation movements are only manual.
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).
Record
Regulatory record for Prorad 2FC | Listed by | Prognosys Medical Systems Private Limited, India |
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Manufacturer |
| 510(k) | K183541 |
| Record published | 2026-05-07 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Storage environment temperature -20 to 60 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 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.