# K221089: P12 Elite Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Sep 15, 2022 after 155 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: 24 generations back to K935595 (1995). 212 ancestors in all.
No later device cites it as a predicate yet.
6 of 213 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 4.

## Indications for use
The P12 Elite Series Digital Color Doppler Ultrasound System (P12 Exp, P12 Elite, P12 Pro, R12, P12N, P11 Exp, P11 Elite, P11 Pro, R11, P11N, P10 Elite, P10N, R10, P9 Elite, M11,R9) is a general-purpose ultrasonic imaging instrument intended for use by a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. The system is applicable for people who need clinical ultrasound examination. Age, weight, health condition and race are unlimited. The system is intended for use in the following clinical applications: 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. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

Source page: https://510kreport.com/device/K221089
Methodology: https://510kreport.com/methodology