# K220993: Ultrasound System SONIMAGE MX1

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta, Inc.
- Decided: Jun 23, 2022 after 80 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 131 ancestors in all.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180084: Ultrasound System SONIMAGE MX1, Konica Minolta, Inc. (2018) Summary page 4.

## Indications for use
The Ultrasound System SONIMAGE MX1 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, musculoskeletal, cardiac, and peripheral vascular. This device is intended for use in healthcare facilities, such as health clinics and hospitals. Intended user for the device are physician, sonographer, and other trained qualified healthcare professionals. Modes of operation include B-mode, M-mode, PWD-mode, CWD-mode, Color Doppler-mode, Power Doppler-mode, and their Combined mode.

Source page: https://510kreport.com/device/K220993
Methodology: https://510kreport.com/methodology