# K171891: ZS3 Ultrasound System, z.one pro Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 21, 2017 after 87 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: 26 generations back to K935595 (1995). 380 ancestors in all.
4 later devices descend from it; 1 cites it directly.
6 of 385 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151175: ZONARE ZS3 Diagnostic Ultrasound System, Zonare Medical Systems, Inc. (2015) Summary page 28.
- K170277: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2017) Summary page 29.
- K160184: Voluson S6, Voluson S8, Voluson S10, GE Healthcare (2016) Summary page 29.
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2016) Summary page 29.
- K152543: M9/M9CV/M9T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 29.

## Most influential descendants
- K192410: ZS3 and z.one pro Ultrasound Systems (2019), 3 descendants of its own
- K222754: ViewMate Multi Ultrasound System (2022), 1 descendant of its own
- K251820: ViewMateTM Ultrasound System (2025), 0 descendants of its own
- K251250: ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (2025), 0 descendants of its own

## Indications for use
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

Source page: https://510kreport.com/device/K171891
Methodology: https://510kreport.com/methodology