Densitometer, Bone
Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or…
Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
Record
| Listed by | Stratec Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Manufacturer |
| 510(k) | K983273 |
| Record published | 2017-04-26 |
| Record revised | 2025-10-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 85 % RH; Storage environment temperature 0 to 50 °C; Handling environment humidity 20 to 80 % RH; Handling environment temperature 18 to 32 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XCT 3000 | In distribution | |
| XCT 2000L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TBS iNsight | Medimaps Group SA | 6 |
| Prodigy | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | 4 |
| 3D-SHAPER | 3D-SHAPER Medical S.L. | 2 |
| QCT PRO Asynchronous 3D Spine and CTXA-Hip System | Mindways Software, Inc. | 2 |
| Horizon Ci | Hologic, Inc. | 1 |
| QCT Pro Asynchronous Calibration Module, CliniQCT | Mindways Software, Inc. | 1 |
| XR-600 Basic | Norland at Swissray | 1 |
| Discovery A | Hologic, Inc. | 1 |
| Medimaps TBS iNsight | Medimaps Group SA | 1 |
| Model 4 CT Calibration Phantom | Mindways Software, Inc. | 1 |
| Discovery SL | Hologic, Inc. | 1 |
| IlluminatusDXA Software | Norland at Swissray | 1 |
Showing 12 of 38. All products under Densitometer, Bone
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.