# K180782: Aria

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Apr 20, 2018 after 25 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: 6 generations back to K890121 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982267: DPX-RX Bone Densitometer, Lunar Corp. (1998) Summary page 6.
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 6.

## Indications for use
X-ray Bone Densitometer designed to estimate the bone mineral density of patients when medically indicated by their physicians. * Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. * 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 10-year fracture risk using WHO FRAX model. * 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.

Source page: https://510kreport.com/device/K180782
Methodology: https://510kreport.com/methodology