Phantom
Phantom: 1 catalogue number listed by Medimaps Group SA, Switzerland, under Densitometer, Bone. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
3510(k) clearances naming this product code
2recalls on this code
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 | Medimaps Group SA, Switzerland |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-05-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3 | 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 |
| 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 |
Showing 12 of 38. All products under Densitometer, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243218 | 2025-01-17 |
| K152299 | 2016-04-29 |
| K121716 | 2012-10-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-03 | Class II | Software Design Change | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. | 2036 units (724 US, 1312 OUS) | |
| 2016-10-03 | Class II | Under Investigation by firm | The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded. | 15 units in US | 2017-06-07 |
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.