# K170078: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley

- Pathway: 510(k) (Abbreviated)
- Applicant: Medisono, LLC
- Decided: May 17, 2017 after 128 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: 20 generations back to K935595 (1995). 204 ancestors in all.
No later device cites it as a predicate yet.
6 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112602: S6 Diagnostic Ultrasound System, Sonoscape Company Limited (2011) Summary page 113.
- K132768: S8 Exp Portable Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2013) Summary page 114.
- K130801: Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2013) Summary page 114.
- K152396: S12 Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2015) Summary page 114.
- K110510: S20 Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2011) Summary page 114.
- K142815: S22 Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2015) Summary page 114.

## Indications for use
The Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley are general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K170078
Methodology: https://510kreport.com/methodology