# K252718: Lunar Astra - Pathway: 510(k) (Traditional) - Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC - Decided: Apr 20, 2026 after 235 days - Product code: KGI (Densitometer, Bone) - Device class: 2 - Regulation: 21 CFR 892.1170 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K890121 (1990). 45 ancestors in all. No later device cites it as a predicate yet. 0 of 46 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K052581: Lunar Idxa, Ge Medical Systems Ultrasound and Primary Care Dia (2005) Summary page 6. - K191112: GEHC DXA Bone Densitometers with enCORE version 18, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2019) Summary page 6. ## Indications for use The x-ray bone densitometer supports the following 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. E) Optional Hand BMD software estimates the BMD at the hand. F) Optional Vertebral Assessment Suite 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 Birth to 20 software 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 HealthCare 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 Neck to Knee software feature provides a complete bone and body composition assessment in one optimized exam including BMD, Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status. Source page: https://510kreport.com/device/K252718 Methodology: https://510kreport.com/methodology