# K200356: Medo Aria

- Pathway: 510(k) (Traditional)
- Applicant: Medo.Ai
- Decided: Jun 11, 2020 after 119 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 87 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191647: QLAB Advanced Quantification Software, Philips Health Care (2019) Summary page 4.

## Most influential descendants
- K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (2024), 2 descendants of its own
- K262390: BoneXpert (2026), 0 descendants of its own
- K250914: MediAI-BA (2025), 0 descendants of its own

## Indications for use
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.

Source page: https://510kreport.com/device/K200356
Methodology: https://510kreport.com/methodology