# K161354: MELODY, Remote Control System for Ultrasound Probe

- Pathway: 510(k) (Traditional)
- Applicant: Adecho Tech
- Decided: Jun 12, 2017 after 392 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K922470 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082543: Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100, Sonocine, Inc. (2008) Summary page 5.

## Most influential descendants
- K260190: Arthur (2026), 0 descendants of its own

## Indications for use
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the patient location from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not on-site provide a second opinion.

Source page: https://510kreport.com/device/K161354
Methodology: https://510kreport.com/methodology