# K231659: MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)

- Pathway: 510(k) (Traditional)
- Applicant: Medisono
- Decided: Feb 15, 2024 after 253 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: 25 generations back to K935595 (1995). 218 ancestors in all.
No later device cites it as a predicate yet.
6 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171000: P60 Series Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2017) Summary page 5.
- K131305: Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased Probe, Chison Medical Imaging Co., Ltd. (2013) Summary page 6.
- K172993: P20 Series Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2017) Summary page 6.
- K132768: S8 Exp Portable Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2013) Summary page 6.

## Indications for use
Indications for Use: The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P9 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 plus 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), Transrectal and Transvaginal.

Source page: https://510kreport.com/device/K231659
Methodology: https://510kreport.com/methodology