Densitometer, Bone
Regulation 892.1170
2510(k)s in 12 months (148 all time)
0recalls in 12 months (26 all time)
21recalls that name a 510(k)
Top companies in KGI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2025 | Medimaps Group Brand Name: TBS Osteo
Product Name: TBS iNsight
Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi
Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0
Product Description: TBS iNsi Open, Classified |
KGI | K152299 |
| Jul 16, 2024 | Hologic Inc Horizon X-Ray Bone Densitometer (DXA)
Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN Open, Classified |
KGI | K023398 |
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer Open, Classified |
KGI | K191112 |
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer Open, Classified |
KGI | K161682 |
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer Open, Classified |
KGI | K133664 |
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA bone densitometer Open, Classified |
KGI | K052581 |
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare:
a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365
b) Prodigy Advanced, Model Number Terminated |
KGI | K982267 |
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare Lunar:
a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369
b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352
Provides an estimate of BMD (Bone Marrow Density) at the lumbar Terminated |
KGI | K873296 |
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare Lunar:
a) DPX Duo, Model Number: LU41693
b) DPX Bravo, Model Number: LU41692
Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD Terminated |
KGI | K030962 |
| Nov 5, 2016 | Medimaps Group TBS iNsight Version v.3.0.1
Product Usage:
TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management. Terminated |
KGI | K152299 |
| Nov 18, 2011 | Cooper Surgical, Inc. DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers.
The XR 46 performs DXA scans of the Terminated |
KGI | K992125 |
| Jan 27, 2010 | Ge Healthcare DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
The systems provide an estimate of BMD. Terminated |
KGI | None listed |
| Jan 27, 2010 | Ge Healthcare DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
The systems provide an estimate of BMD. Terminated |
KGI | None listed |
| Jan 27, 2010 | Ge Healthcare DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
The systems provide an estimate of BMD. Terminated |
KGI | None listed |
| Jan 27, 2010 | Ge Healthcare Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
The systems provide an estimate of BMD Terminated |
KGI | None listed |
| Jan 27, 2010 | Ge Healthcare iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
The systems provide an estimate of BMD Terminated |
KGI | None listed |
| Aug 25, 2009 | Hologic, Inc. Hologic Delphi series Bone Densitometer
Software versions 12.6, 2.3., or 2.4
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR s Terminated |
KGI | K072847 |
| Aug 25, 2009 | Hologic, Inc. Hologic QDR 4500 series Bone Densitometer
Software versions 12.6, 2.3., or 2.4
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR Terminated |
KGI | K072847 |
| Aug 25, 2009 | Hologic, Inc. Hologic Explorer series Bone Densitometer System
Software versions 12.6, 2.3., or 2.4.
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a Terminated |
KGI | K072847 |
| Aug 25, 2009 | Hologic, Inc. Hologic Discovery series Bone Densitometer System
Software versions 12.6, 2.3., or 2.4.
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a Terminated |
KGI | K072847 |
| Dec 29, 2008 | Hologic, Inc. Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software Terminated |
KGI | K080711 |
| Sep 17, 2008 | Hologic, Inc. Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a da Terminated |
KGI | K072847 |
| Sep 17, 2008 | Hologic, Inc. Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | K072847 |
| Sep 17, 2008 | Hologic, Inc. Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a Terminated |
KGI | K072847 |
| Sep 17, 2008 | Hologic, Inc. Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | K072847 |
| Sep 17, 2008 | Hologic, Inc. Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | K072847 |
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