# K191112: GEHC DXA Bone Densitometers with enCORE version 18

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Sep 19, 2019 after 146 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890121 (1990). 34 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 6.
- K152299: TBS iNsight, Medimaps Group SA (2016) Summary page 6.

## Most influential descendants
- K252718: Lunar Astra (2026), 0 descendants of its own
- K251022: 3D-Shaper (2025), 0 descendants of its own

## Recalls of this device
- Dec 3, 2019 · Class II · Z-1712-2020: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

## Indications for use
A) Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Total Body, and Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. B) Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). C) Provides an assessment of 10-year fracture risk using WHO FRAX model. D) Provides a standardized bone density report using data from the densitometer and physician-generated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient and the patient's referring physician. Optional Hand BMD software estimates the BMD at the hand. E) Optional Hand BMD software estimates the BMD at the hand. F) Optional Dual-Energy Vertebral Assessment software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry). G) Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery). H) Optional Complete Pediatric software option measures bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the physician. The software does not provide a reference population for comparative purposes for patients younger than 5 years of age. I) Optional Body Composition software measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass, and calculates other derivative values which can be displayed in user-defined statistical formats and trends and compared to reference populations at the sole discretion of the healthcare professional. Some of the diseases/conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. J) The MirrorImage function used on the GE Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the body. K) Optional CoreScan software estimates the Visceral Adipose Tissue (VAT) content and the Subcutaneous Adipose Tissue (SAT) content within the android region in a male or female population between the ages of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the VAT Mass, VAT Volume, VAT Area, SAT Mass, SAT Volume, and SAT Area. The values can be displayed in user-defined statistical formats and trends. Some of the diseases/conditions for which VAT estimation can be useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, metabolic syndrome, and some cancers that are correlated to adipose tissue inflammation. L) Optional total body composition software estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. M) Optional total body composition software estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. N) Optional Advanced Hip Assessment (AHA) software provides a measurement of hip axis length (HAL) and a mean value of HAL for Caucasian and Asian females on femur images. It also calculates hip geometry values used to evaluate the structural properties of the hip. O) Optional Atypical Femur Fracture (AFF) software uses femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. P) Optional sarcopenia software calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance. These values may be useful to health care professionals in their management of sarcopenia. Q) Optional DXAVision software feature provides a complete bone and body composition assessment in one optimized exam including BMD with TBS, Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status. R) TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO’s FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers…). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease or recommend treatment regimens. Only the health care professional can make these judgments.

Source page: https://510kreport.com/device/K191112
Methodology: https://510kreport.com/methodology