# K163688: Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

- Pathway: 510(k) (Abbreviated)
- Applicant: Medisono, LLC
- Decided: Feb 23, 2017 after 57 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: 19 generations back to K935595 (1995). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122574: Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6, Edan Instruments, Inc. (2012) Summary page 32.
- K110999: Digital Ultrasonic Diagnostic Imaging System, Edan Instruments, Inc. (2011) Summary page 32.
- K123249: Diagnostic Ultrasound System, Edan Instruments, Inc. (2013) Summary page 32.

## Indications for use
The MEDISONO Ultracnic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic. Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta and Transvagina.

Source page: https://510kreport.com/device/K163688
Methodology: https://510kreport.com/methodology