# K171000: P60 Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Jul 11, 2017 after 99 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: 23 generations back to K935595 (1995). 211 ancestors in all.
4 later devices descend from it; 4 cite it directly.
6 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160283: S45 Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2016) Summary page 50.

## Most influential descendants
- K241949: Digital Color Doppler Ultrasound System (P60 Series) (2025), 0 descendants of its own
- 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) (2024), 0 descendants of its own
- K221089: P12 Elite Series Digital Color Doppler Ultrasound System (2022), 0 descendants of its own
- K221140: P20 Elite Series Digital Color Doppler Ultrasound System (2022), 0 descendants of its own

## Indications for use
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument 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, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

Source page: https://510kreport.com/device/K171000
Methodology: https://510kreport.com/methodology