# K162065: Ultrasound System SONIMAGE HS1

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta, Inc.
- Decided: Oct 19, 2016 after 85 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 129 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152577: Ultrasound System Sonimage HS 1, Konica Minolta, Inc. (2015) Summary page 13.
- K061605: Nemio XG, Saa-580A, Toshiba America Medical Systems, In.C (2006) Summary page 13.
- K142368: Noblus Diagnostic Ultrasound Scanner, Hitachi Aloka Medical, Ltd. (2015) Summary page 13.

## Most influential descendants
- K180084: Ultrasound System SONIMAGE MX1 (2018), 1 descendant of its own
- K220993: Ultrasound System SONIMAGE MX1 (2022), 0 descendants of its own

## Recalls of this device
- Dec 4, 2017 · Class II · Z-1214-2018: There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
- Apr 24, 2017 · Class II · Z-2769-2017: The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

## Indications for use
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.

Source page: https://510kreport.com/device/K162065
Methodology: https://510kreport.com/methodology