MiniCAT 2d
The MiniCAT 2D is a diagnostic X-ray system for general radiographic imaging of the head and neck. It acquires a rotational X-ray sequence and produces two dimensional views for use in…
The MiniCAT 2D is a diagnostic X-ray system for general radiographic imaging of the head and neck. It acquires a rotational X-ray sequence and produces two dimensional views for use in hospitals, clinics, imaging centers and medical practices.
The system combines a high voltage generator, X-ray tube, fixed detector panel and motorized overhead gantry. The gantry rotates through 360 degrees around the patient, with an operator computer providing the user interface.
Listed Item
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
Patient Positioning
A motorized height adjustable chair supports the patient during imaging, with a maximum patient weight of 159 kg. Forward and backward positioning supports sinus and ear examinations. The system uses its detector and control electronics to acquire the image sequence.
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
Record
| Listed by | Xoran Technologies, LLC, United States |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K201825 |
| Record published | 2023-07-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10035 | In distribution | |
| 10030 | In distribution | |
| 10031 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 171 |
| Q-RAD System | Carestream Health, Inc. | 159 |
| DRX – Ascend System | Carestream Health, Inc. | 121 |
| FDR Clinica | Drgem Corporation | 41 |
| RADspeed Pro | Shimadzu Corp. | 31 |
| FDR Visionary Suite | Shimadzu Corp. | 17 |
| Exsys DEXi | Drtech Corporation | 15 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| GXR-Es,ecs Diagnostic X-ray System | Drgem Corporation | 14 |
| X-CEL X-RAY Corporation | Arquilla, Inc. | 14 |
| DRX-Evolution Plus System | Carestream Health, Inc. | 12 |
| Carestream DRX-Evolution | Carestream Health, Inc. | 10 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201825 | 2020-11-20 |
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.