# K260192: DIANA

- Pathway: 510(k) (Traditional)
- Applicant: ROPCA ApS
- Decided: Jul 24, 2026 after 183 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: 16 generations back to K935595 (1995). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222406: Clarius AI, Clarius Mobile Health Corp. (2023) Summary page 5.

## Indications for use
DIANA is intended for use in patients undergoing ultrasound examination of the hand and wrist joints. The device automatically analyzes musculoskeletal structures on pre-captured ultrasound images and provides decision support for identification of Synovial hypertrophy, Doppler activity, and Osteophytes presence/absence. The user of the decision support shall be a healthcare professional trained and qualified in musculoskeletal (MSK) ultrasound. DIANA is limited to use with the system ARTHUR which performs automatic acquisition of ultrasound images.

Source page: https://510kreport.com/device/K260192
Methodology: https://510kreport.com/methodology