Home › Device types › KGI
Densitometer, Bone
FDA product code KGI · Class 2 · Radiology
49
Registered devices
57
Adverse events
26
Recalls
147
510(k) clearances
Devices with this code
NA — Stratec Medizintechnik GmbH3D-SHAPER — 3D-SHAPER MEDICAL S.L.TBS iNsight — medimaps group SAQCT PRO 3D Volumetric Spine and CTXA Hip Software — MINDWAYS SOFTWARE, INC.QCT PRO 3D Volumetric Spine and CTXA Hip System — MINDWAYS SOFTWARE, INC.Horizon A — Hologic, Inc.IlluminatusDXA Software — Norland at SwissrayCTXA Hip Bone Mineral Densitometer — MINDWAYS SOFTWARE, INC.Phantom — medimaps group SADiscovery Wi — Hologic, Inc.Horizon Ci — Hologic, Inc.Discovery W — Hologic, Inc.QCT PRO Asynchronous 3D Spine and CTXA-Hip System — MINDWAYS SOFTWARE, INC.XR-600 Advanced — Norland at SwissrayQCT PRO 3D Volumetric Spine System — MINDWAYS SOFTWARE, INC.QCT PRO Asynchronous 3D Spine Software — MINDWAYS SOFTWARE, INC.Horizon Wi — Hologic, Inc.VirtuOst — O N DIAGNOSTICS LLCCTXA Hip Extended Reference Data — MINDWAYS SOFTWARE, INC.QCT PRO 3D Volumetric Spine Software — MINDWAYS SOFTWARE, INC.Prodigy — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCQCT PRO Asynchronous 3D Spine and CTXA-Hip System — MINDWAYS SOFTWARE, INC.TBS iNsight — medimaps group SANA — Stratec Medizintechnik GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-03 | Medimaps Group | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. |
| 2024-06-13 | Hologic Inc | Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essent |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | 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 infor |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | 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 infor |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | 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 infor |
| 2016-10-03 | Medimaps Group | 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 vert |
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