Lunar Astra Bone Densitometer
by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 510(k)
Active
510(k) K252718
Overview
The Lunar Astra is a bone densitometer, a medical imaging device designed to measure bone mineral density (BMD) and assess fracture risk. It employs dual-energy X-ray absorptiometry (DXA) technology to provide precise quantitative assessments of bone health, primarily in the lumbar spine, hip, and forearm regions. This data aids clinicians in diagnosing osteoporosis, monitoring treatment efficacy, and evaluating fracture risk in patients. The device adheres to the classification of a Class 2 Radiology device under FDA regulations.
The Lunar Astra is supplied with proprietary software (Lunar Software v1.0) and is intended for use in radiology settings, including hospitals, clinics, and research facilities. It is not described as single-use or reusable in the provided data, though its operational lifecycle is governed by FDA clearance (K252718) under the Traditional 510(k) pathway. The device operates within regulatory parameters defined by the FDA’s product code KGI and regulation number 892.1170, ensuring compliance with safety and performance standards for bone densitometry. No specific sterility or MRI safety information is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252718 | Date20 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Lunar Astra
- 510(k) Number
- FDA Product Code
- KGI
- FDA applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1170
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What specific body regions does the Lunar Astra measure for bone mineral density (BMD) and how does this help clinicians?
The Lunar Astra uses dual-energy X-ray absorptiometry (DXA) to measure bone mineral density in the lumbar spine, hip, and forearm regions. These measurements help clinicians diagnose osteoporosis, evaluate fracture risk, and monitor treatment effectiveness by providing quantitative assessments of bone health in critical areas prone to fractures.
Is the Lunar Astra designed for single-use or can it be reused in clinical settings?
The provided data does not specify whether the Lunar Astra is single-use or reusable. However, as a Class 2 Radiology device, it is intended for repeated use in radiology settings like hospitals, clinics, and research facilities, where durability and consistent performance are expected. Reuse would depend on manufacturer guidelines and maintenance protocols.
What software version comes with the Lunar Astra, and is it compatible with standard radiology workflows?
The Lunar Astra is supplied with proprietary software labeled as *Lunar Software v1.0*. While the data does not detail workflow integration, its classification as a bone densitometer and intended use in radiology settings suggests it is designed to support clinical workflows for bone health assessments, including diagnostic reporting and treatment monitoring.
How is the Lunar Astra regulated by the FDA, and what does this mean for its use in clinical practice?
The Lunar Astra is cleared by the FDA under the Traditional 510(k) pathway (K252718) as a Class 2 Radiology device, categorized under product code *KGI* and regulation *892.1170*. This clearance indicates it meets FDA standards for safety and performance in measuring bone mineral density, allowing its use in radiology settings like hospitals and clinics for diagnosing osteoporosis and assessing fracture risk.
Are there multiple models or configurations of the Lunar Astra, and if so, how do they differ?
The provided data lists multiple registration numbers (e.g., 3008921184, 3031503890) under the Lunar Astra, which may correspond to different models or configurations. These variations could relate to technical specifications, software versions, or regional adaptations, but the core functionality—measuring BMD via DXA—remains consistent across all. For exact differences, refer to the manufacturer’s documentation or contact GE Medical Systems.