Lunar iDXA
Assy, Warehouse Ready, iDXA2, MTY
1manufacturer
1catalogue number
4510(k) clearances naming this product code
3recalls 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 | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC, United States |
|---|---|
| FDA product code | KGI |
| Device type | Densitometer, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1170 |
| Establishment | Remanufacturer, Specification developer, Manufacturer |
| 510(k) | K052581 |
| Record published | 2016-06-27 |
| Record revised | 2026-02-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 18 to 27 °C; Storage environment temperature -30 to 65 °C; Storage environment humidity 0 to 95 % RH; Handling environment humidity 20 to 80 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F1 | 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 |
|---|---|
| K252718 | 2026-04-20 |
| K191112 | 2019-09-19 |
| K180782 | 2018-04-20 |
| K161682 | 2016-12-02 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2019-12-03 | Class II | Radiation Control for Health and Safety Act | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | 123 in total |
| GE Medical Systems, LLC | 510(k) number | 2019-12-03 | Class II | Radiation Control for Health and Safety Act | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | 123 in total |
| GE Medical Systems, LLC | 510(k) number | 2019-12-03 | Class II | Radiation Control for Health and Safety Act | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | 123 in total |
| GE Medical Systems, LLC | 510(k) number | 2019-12-03 | Class II | Radiation Control for Health and Safety Act | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. | 123 in total |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-03-16 | Class II | Software design | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on th | 303 units | 2020-12-14 |
| 2018-03-16 | Class II | Software design | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on th | 26 units | 2020-12-14 |
| 2018-03-16 | Class II | Software design | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on th | 43 units | 2020-12-14 |
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.