# K201059: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Jul 30, 2020 after 100 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.
4 later devices descend from it; 1 cites it directly.
6 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172082: S60 Series Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2017) Summary page 4.

## Most influential descendants
- K222596: S90 Exp Series Digital Color Doppler Ultrasound System (2023), 3 descendants of its own
- K254027: Digital Color Doppler Ultrasound System  (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) (2026), 0 descendants of its own
- K254028: Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) (2026), 0 descendants of its own
- K252498: Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (2025), 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. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K201059
Methodology: https://510kreport.com/methodology