3D-SHAPER
3D-SHAPER is software that estimates the three dimensional shape and bone mineral density of the hip from conventional two dimensional DXA scans. It helps qualified medical professionals…
3D-SHAPER is software that estimates the three dimensional shape and bone mineral density of the hip from conventional two dimensional DXA scans. It helps qualified medical professionals assess bone health and changes in bone structure.
The software measures bone mineral distribution in cortical and trabecular compartments and calculates structural properties at selected hip cross sections. Results include density measurements and geometric measures such as cross sectional area, section modulus and buckling ratio.
Patient Restrictions
The software supports clinical judgment rather than replacing it. It is not suitable for pediatric patients or patients with hip prostheses, including total hip replacements, resurfacing prostheses or osteosynthesis systems. These conditions are outside its evaluated use.
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 | 3D-SHAPER Medical S.L., Spain |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Manufacturer |
| 510(k) | K220822 |
| Record published | 2023-10-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.11 | In distribution | |
| 2.14 | 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 |
| QCT PRO Asynchronous 3D Spine and CTXA-Hip System | Mindways Software, Inc. | 2 |
| Densitometer, Bone | Stratec Medizintechnik Gmbh | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251022 | 2025-09-05 |
| K220822 | 2022-12-09 |
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.