← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K252718

# Lunar Astra (K252718)

_GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · KGI · Apr 20, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K252718

## Device Facts

- **Applicant:** GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md)
- **Decision Date:** Apr 20, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1170
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric

## Indications for Use

The bone densitometer is designed to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by a licensed healthcare professional.

## Device Story

Lunar Astra is a dual-energy X-ray absorptiometry (DXA) bone densitometer; uses X-ray source and detector to measure attenuation of two energy levels through body; calculates bone mineral density (BMD), bone mineral content (BMC), and body composition (lean/fat tissue). Operated by medical professionals at a PC workstation; inputs patient data manually or via HIS; produces standardized reports for clinical decision-making regarding osteoporosis, fracture risk, and metabolic status. Features include optional software for pediatric assessment, orthopedic implant analysis, sarcopenia management, and visceral adipose tissue (VAT) estimation. System includes internal QA block and e-delivery software updates. Benefits include non-invasive assessment of bone health and body composition to aid in diagnosis and treatment monitoring.

## Clinical Evidence

Bench testing only; precision and accuracy validated using anthropomorphic phantoms representing adult, pediatric, and infant anatomies. BMD, BMC, and body composition metrics met predefined specifications. Clinical images provided for evaluation of LunarVision feature. No clinical trials reported.

## Technological Characteristics

Dual-energy X-ray absorptiometry (DXA); 76kV/3.5mA X-ray source with Cerium K-edge filter; CdTe photon-counting detector (1.2 x 1.2 mm pitch); internal QA block; Windows-based PC workstation; e-delivery software distribution; supports spine, femur, total body, forearm, hand, and orthopedic implant scanning.

## Regulatory Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Predicate Devices

- Lunar iDXA ([K052581](/device/K052581.md))
- GEHC DXA Bone Densitometer with enCORE version 18 ([K191112](/device/K191112.md))

## Submission Summary (Full Text)

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>
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FDA U.S. FOOD & DRUG ADMINISTRATION

April 20, 2026

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
% Christopher Paulik
Senior Manager, Regulatory Affairs
3030 Ohmeda Drive
MADISON, WI 53718

Re: K252718
Trade/Device Name: Lunar Astra
Regulation Number: 21 CFR 892.1170
Regulation Name: Bone densitometer
Regulatory Class: Class II
Product Code: KGI
Dated: March 12, 2026
Received: March 12, 2026

Dear Christopher Paulik:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252718 – Christopher Paulik
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252718 – Christopher Paulik
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

GABRIELA Digitally signed
by GABRIELA M. for
M. RODAL -S RODAL -S

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K252718

Device Name
Lunar Astra

Indications for Use (Describe)
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,

FORM FDA 3881 (8/23)
PBC Publishing Services (301) 443-6740

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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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)

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PSC Publishing Services (301) 443-6740

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K252718

GE Healthcare

510(k) Premarket Notification Submission – Lunar Astra

GE HealthCare

# 510(k) Summary:

In accordance with 21 CFR 807.92 the following summary information is provided:

|  Date: | April 20, 2026  |
| --- | --- |
|  Owner/Submitter: | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
3030 Ohmeda Dr, Madison, WI 53718, United States  |
|  Primary Contact Person: | Christopher Paulik
Senior Regulatory Affairs Manager
Email: Christopher.A.Paulik@gehealthcare.com
Contact Phone Number: +1 (262) 8945415  |
|  Secondary Contact Person: | Gregory Pessato
Regulatory Affairs Director
Email: Gregory.pessato@gehealthcare.com
Contact Phone Number: +33130704040  |
|  Device Trade Name: | Lunar Astra  |
|  Common/Usual Name: | Bone densitometer  |
|  Regulation Name: | Bone densitometer  |
|  Regulation: | 21 CFR 892.1170  |
|  Classification: | Class II  |
|  Product Code: | KGI  |
|  Predicate Device: | Lunar iDXA (K052581)
21 CFR 892.1170 (KGI)
Class II  |
|  Secondary Predicate Device: | GEHC DXA Bone Densitometer with enCORE version 18 (K191112)
21 CFR 892.1170 (KGI)
Class II  |
|  Manufacturing site: | GE Hualun Medical Systems Co., Ltd.
No. 1, Yong Chang North Road, Beijing Economic Technological Development Zone,
100176 Beijing, P.R. China  |
|  Device Description: | The Lunar Astra with Lunar Software v1.0 is intended to measure bone mineral density and body composition (lean and fat tissue mass) when medically indicated by a licensed healthcare professional. It can be used to perform BMD (Bone Mineral Density) measurements of the spine, femur, forearm, hand, orthopedic hip and knee, total body, body composition measurements of regional and whole body, as well as imaging applications for lateral spine vertebral deformation assessment and atypical femur fracture assessment. Applications can be performed with the patient lying in the supine (spine, femur, forearm, hand, orthopedic hip and knee, total body) or decubitus (lateral spine) position or sitting next to the system (forearm and hand). The intended users are medical professionals with knowledge and experience required to work with x-ray equipment.  |
|  Technology: | The proposed Lunar Astra with Lunar Software v1.0 uses the same fundamental technology and principles of operation as the predicates Lunar iDXA (K052581) and  |

Property of GE Healthcare

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GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra
^{}[]
GE HealthCare

|   | enCORE version 18 (K191112). A technique called dual-energy X-ray absorptiometry (DXA) is used to measure the attenuation of x-rays of two different energy levels after they pass through the body of a subject. As bone, fat tissue, and lean tissue absorb the different energy x-rays at different rates, the relative attenuation of each x-ray energy is measured (referred to as count rates) and used to calculate the composition of each pixel. The primary components of Lunar Astra with Lunar Software v1.0 remain the same as the predicate device: (1) an x-ray source (2) an x-ray detector (3) a support / table for holding the subject between source and detector (4) a mechanical means to move the source and detector (5) software and electronic controls for the previously mentioned components. The user operates the Lunar Astra from a PC workstation loaded with the Lunar Software v1.0 on a Windows operating system. The user inputs the patient information directly, from a database stored in the software, or via a hospital information system (HIS). The prescribed area is then scanned to acquire the data used to compute the bone mineral density, lean and fat tissue mass for the study. The results of the study can then be viewed on the computer display, printed, and/or transmitted via network to PACS or EMR for archival. The basic acquisition and scan modes (modes of operation) as well as computer algorithms (formulae and techniques) used to compute bone mineral density, lean and fat tissue mass retain the same function and characteristics as used on the predicate device.  |
| --- | --- |

Property of GE Healthcare
Page 3 of 15

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GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

GE HealthCare

|  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.  |
| --- | --- |

Property of GE Healthcare
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GE Healthcare

510(k) Premarket Notification Submission - Lunar Astra

GE HealthCare

|   | 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.  |

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE:

High- level comparison between predicate and subject device is provided below in Table 1.

Table 1: High-level Comparison of Subject Device to Predicate

Property of GE Healthcare

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GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar iDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|  Intended Use | The bone densitometer is designed to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. | The bone densitometer is designed to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. | The bone densitometer is designed to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by a licensed healthcare professional. | Same as both Predicates
Intended use for Lunar Astra with Lunar Software v1.0 is clarified from “physician” to “by a licensed healthcare professional”.  |
|  Indications for Use (IFU) | The Lunar iDXA Bone Densitometer provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician. | The x-ray bone densitometer supports the following indications for use: | The x-ray bone densitometer supports the following indications for use: | The subject device’s IFU is broader but contains the primary predicate’s IFU and is similar to the secondary predicate’s IFU. Refer to the rows below.  |
|  IFU A) | N/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. | 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. | Identical to Secondary Predicate  |
|  IFU B) | N/A | 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). | 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). | Identical to Secondary Predicate  |
|  IFU C) | N/A | Provides an assessment of 10-year fracture risk using WHO FRAX model. | Provides an assessment of 10-year fracture risk using WHO FRAX model. | Identical to Secondary Predicate  |
|  IFU D) | N/A | 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. | 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. | Identical to Secondary Predicate  |

Property of GE Healthcare
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GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|  IFU E) | N/A | Optional Hand BMD software estimates
the BMD at the hand. | Optional Hand BMD software estimates
the BMD at the hand. | Identical to Secondary Predicate  |
|  IFU F) | N/A | 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) | 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) | Identical to Secondary Predicate
“Dual-Energy Vertebral Assessment” is
rebranded as “Vertebral Assessment
Suite”. No change in functionality  |
|  IFU G) | N/A | Optional Orthopedic software estimates
periprosthetic BMD of an orthopedic hip
or knee implant (pre- and post-surgery). | Optional Orthopedic software estimates
periprosthetic BMD of an orthopedic hip
or knee implant (pre- and post-surgery). | Identical to Secondary Predicate  |
|  IFU H) | N/A | 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. | 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. | Identical to Secondary Predicate
“Complete Pediatric” is rebranded as
“Birth to 20”. No change in functionality  |
|  IFU I) | N/A | 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 | 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 | Identical to Secondary Predicate  |

Property of GE Healthcare
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GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|   |  | 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. | 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. |   |
|  IFU J) | N/A | 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. | 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. | Identical to Secondary Predicate  |
|  IFU K) | N/A | 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. | 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. | Identical to Secondary Predicate  |

Property of GE Healthcare
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{12}

GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|  IFU L) | N/A | 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. | 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. | Identical to Secondary Predicate  |
|  IFU M) | N/A | 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 | 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 | Identical to Secondary Predicate  |
|  IFU N) | N/A | 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. | 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. | Identical to Secondary Predicate  |
|  IFU O) | N/A | 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. | 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. | Identical to Secondary Predicate  |
|  IFU P) | N/A | Optional sarcopenia software calculates
values based on published definitions
and thresholds using measured | Optional sarcopenia software calculates
values based on published definitions
and thresholds using measured | Identical to Secondary Predicate  |

Property of GE Healthcare
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{13}

GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|   |  | 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. | 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 |   |
|  IFU Q) | N/A | 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. | 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. | Identical to Secondary Predicate “DXAVision” is rebranded as “Neck-to-Knee”. No change in functionality  |
|  IFU R) | N/A | 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 | N/A | Removed from Secondary Predicate The Trabecular Bone Score (TBS) software option (cleared in K152299) is now distributed as standalone software that is provided by the original equipment manufacturer (OEM) Medimaps. This required GEHC to remove this option as embedded within the Lunar Software v1.0, which is a change to how TBS was distributed in the secondary predicate device enCORE version 18. No change in functionality.  |

Property of GE Healthcare
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{14}

GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|   |  | 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. |  |   |
|  Contraindications | No contraindications | No contraindications | No contraindications | Identical to both Predicates  |
|  Environment of use | Prescription only | Prescription only | Prescription only | Identical to both Predicates  |
|  Intended Users | Medical professionals with knowledge and experience required to work with x-ray equipment. Prescription use only. | Medical professionals with knowledge and experience required to work with x-ray equipment. Prescription use only. | Medical professionals with knowledge and experience required to work with x-ray equipment. Prescription use only. | Identical to both Predicates  |
|  Patient Population | Intended patient population is pediatrics (age 0-19), adults, and elderly (over 65 years old). | Intended patient population is pediatrics (age 0-19), adults, and elderly (over 65 years old). | Intended patient population is pediatrics (age 0-19), adults, and elderly (over 65 years old). | Identical to both Predicates  |

Property of GE Healthcare
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{15}

GE Healthcare

510(k) Premarket Notification Submission - Lunar Astra

GE HealthCare

|  Specification | Primary Predicate Device
Lunar iDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|  X-Ray Tube
Assembly | 100kV/2.5mA monoblock
Insert: Lohmann X-ray GmbH 110/3
EFK
K-edge filter: Samarium | N/A- Not a software component,
comparison is done with the primary
predicate device Lunar iDXA (K052581) | 76kV/3.5mA monoblock
Insert: Wansen 105739-170
K-edge filter: Cerium | Changed from Primary Predicate
Lunar Astra tube uses a different tube
insert with lower kV and higher mA. K-edge filter material is changed to provide
optimal energy separation for the kV used.
The Lunar Astra X-ray source reaches the
needed energy level quickly, so it does not
need a mechanical shutter to start or stop
the X-ray exposure.  |
|  Effective Energy
(KeV) | 40 KeV Low Energy Peak/72 KeV High
Energy Peak | N/A- Not a software component,
comparison is done with the primary
predicate device Lunar iDXA (K052581) | 37 KeV Low Energy Peak/59 KeV High
Energy Peak | Changed from Primary Predicate
The decrease in KeV is due to lowering the
X-ray tube voltage from 100 kV to 76 kV.
This change does not affect functionality,
because the system automatically adjusts
for the difference in X-ray signals. It uses
these adjusted values to calculate fat
fraction, tissue thickness, bone mineral
density, etc.  |
|  Detector | Material CdTe
Detector pitch of 2.5 x 0.8 mm
Image resolution: 1.2- 1.6lp/mm
(depending on direction) | N/A- Not a software component,
comparison is done with the primary
predicate device Lunar iDXA (K052581) | Material CdTe
Detector pitch of 1.2 x 1.2 mm
Image resolution: 1.2-1.3lp/mm
(depending on direction) | Changed from Primary Predicate
The Lunar Astra detector uses same
material (CdTe) and technology (photon
counting). The image pixel size was
adjusted for tube power and distance
between the X-ray source and the image
detector differences to maintain the same
BMD precision as the predicate.  |
|  Collimator | Narrow-angle fan beam with Shutter | N/A-Not a software component,
comparison is done with the primary
predicate device Lunar iDXA (K052581) | Narrow-angle fan beam, No shutter,
beam collimation only | Changed from Primary Predicate
The Lunar Astra does not provide a shutter
to initiate / terminate an acquisition (refer
to “X-Ray Tube Assembly” change in this
table)  |
|  Scanner Table | 1) Max scan window (WxL): 66x198
cm
2) Max patient weight: 500 lbs | N/A- Not a software component,
comparison is done with the primary
predicate device Lunar iDXA (K052581) | 1) Max scan window (WxL): 67x198 cm
2) Max patient weight: 525 lbs
3) Table pad: Polyethylene foam with | Changed from Primary Predicate
The Lunar Astra scanner table supports
heavier patients, has a wider transverse  |

Property of GE Healthcare

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{16}

GE Healthcare

510(k) Premarket Notification Submission – Lunar Astra

GE HealthCare

|  Specification | Primary Predicate Device
Lunar iDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|   | 3) Table pad: Urethane-coated fabric material over foam core. Imprinted scan window outline |  | Polyurethane outer skin. Raised scan window outline | scan window range, and an updated table pad.  |
|  Scan Arm Control Panel | Push button and indicator lights. Emergency stop, Positioning buttons, Start scan button | N/A- Not a software component, comparison is done with the primary predicate device Lunar iDXA (K052581) | Push button and indicator lights. Emergency stop, Positioning buttons, Start scan button, Home and Stop buttons | Changed from Primary Predicate Lunar Astra adds Home and Stop buttons to the control panel to allow the operator to perform these functions at the device in addition to the workstation.  |
|  Quality Assurance (QA) Block | External | N/A- Not a software component, comparison is done with the primary predicate device Lunar iDXA (K052581) | Internal | Changed from Primary Predicate Lunar Astra daily QA block is now built into the table in a fixed position where QA is performed. The internal QA block provides the same function but is internal to the system.  |
|  Exposure Time (Standard mode) | - AP Spine: 30 sec
- Femur: 30 sec
- Total Body: 339 sec | - AP Spine: 30 sec
- Femur: 30 sec
- Total Body: 339 sec | - AP Spine: 28 sec
- Femur: 28 sec
- Total Body: 225 sec | Changed from Primary Predicate Lunar Astra Total Body scans use a faster speed, resulting in a lower exposure time. Scan speeds for spine and femur are similar.  |
|  Skin Entrance Dose (Standard mode) | - AP Spine: 146 μGy
- Femur: 146 μGy
- Total Body: 3 μGy | - AP Spine: 146 μGy
- Femur: 146 μGy
- Total Body: 3 μGy | - AP Spine: 72 μGy
- Femur: 72 μGy
- Total Body: 3 μGy | Changed from Primary Predicate Lunar Astra scans are lower dose compared to Lunar iDXA due to lower kV tube but are able to achieve the same performance.  |
|  Precision | - AP Spine L1-L4/L2-L4 BMD: 1.0% (0.010 g/cm2)
- Femur Total BMD: 1.0% (0.010 g/cm2)
- Total Body Total BMD: 1.0% (0.010 g/cm2)
- Precision for other sites will range 1-3%. | - AP Spine L1-L4/L2-L4 BMD: 1.0% (0.010 g/cm2)
- Femur Total BMD: 1.0% (0.010 g/cm2)
- Total Body Total BMD: 1.0% (0.010 g/cm2)
- Precision for other sites will range 1-3%. | - AP Spine L1-L4/L2-L4 BMD: 1.0% (0.010 g/cm2)
- Femur Total BMD: 1.0% (0.010 g/cm2)
- Total Body Total BMD: 1.0% (0.010 g/cm2)
- Precision for other sites will range 1-3%. | Identical to both Predicates  |

Property of GE Healthcare

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{17}

GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

|  Specification | Primary Predicate Device
Lunar IDXA (K052581) | Secondary predicate device
enCORE version 18
(K191112) | Proposed Device
Lunar Astra with Lunar
Software v1.0 | Discussion of differences
between Proposed device and
Predicate device  |
| --- | --- | --- | --- | --- |
|  Accuracy | Within 0.030 g/cm2 of its expected
value which ensures the linear
correlation for BMD (R ≥ 0.99) | Within 0.030 g/cm2 of its expected
value which ensures the linear
correlation for BMD (R ≥ 0.99) | Within 0.030 g/cm2 of its expected
value which ensures the linear
correlation for BMD (R ≥ 0.99) | Identical  |
|  Algorithm | N/A- Software, comparison is done
with the secondary predicate device
enCORE version 18 (K191112) | Calibration, daily QA, acquisition and
analysis algorithms. | Calibration, daily QA, acquisition and
analysis algorithms. | Changed from Secondary Predicate
Basic acquisition, scan modes and
computer algorithms used to compute
bone mineral density, lean and fat tissue
mass retain the same function and
characteristics as their current usage.
The updates were due to the introduction
of the Lunar Astra hardware.  |
|  eDelivery | N/A- Software, comparison is done
with the secondary predicate device
enCORE version 18 (K191112) | Not available | Available | Changed from Secondary Predicate
Lunar Software v1.0 allows the software
to be delivered remotely over the internet
(called e-Delivery), instead of using a DVD
or USB like the current enCORE version
18. No change to installation package,
only delivery way is different.  |

Property of GE Healthcare
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{18}

GE Healthcare
510(k) Premarket Notification Submission – Lunar Astra

# PERFORMANCE DATA: Determination of Substantial Equivalence

## Summary of Non-Clinical Tests:

The following quality assurance measures were applied to the development of Lunar Astra with Lunar Software v1.0:

1. Risk Analysis
2. Requirements Reviews
3. Design Reviews
4. Testing on unit level (Module verification)
5. Integration testing (System verification)
6. Performance testing (Verification)
7. Safety testing (Verification)
8. Simulated use testing (Validation)

The precision and accuracy testing was performed using multiple anthropomorphic phantoms representing clinical sites across adult, pediatric, and infant anatomies. Lunar Astra with Lunar Software v1.0 was evaluated for BMD, BMC, and body composition metrics, with results compared to predefined specifications and predicate device. Additional bench tests assessed image resolution and verified software features. All tests met acceptance criteria, demonstrating substantial equivalence in safety and effectiveness.

The Lunar Astra with Lunar Software v1.0 verification and validation testing was performed to confirm that the safety and effectiveness of the device have not been affected. The test plans and results have been executed with acceptable results. Conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

## Summary of Clinical testing:

Clinical images were provided for the evaluation of the LunarVision feature.

## CONCLUSION:

The design verification and validation testing and bench testing demonstrated that Lunar Astra with Lunar Software v1.0 is as safe, as effective, and substantially equivalent to the predicate device.

Property of GE Healthcare

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K252718](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K252718)

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**Cite:** Innolitics at https://innolitics.com