# K192410: ZS3 and z.one pro Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 19, 2019 after 106 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: 27 generations back to K935595 (1995). 381 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K171891: ZS3 Ultrasound System, z.one pro Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2017) Summary page 31.

## Most influential descendants
- 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 Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; 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/K192410
Methodology: https://510kreport.com/methodology