# K251820: ViewMateTM Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 12, 2025 after 91 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: 28 generations back to K935595 (1995). 382 ancestors in all.
No later device cites it as a predicate yet.
6 of 383 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192410: ZS3 and z.one pro Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 5.

## Indications for use
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals 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 ultrasound system is 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. Modes of operation include: B (Includes B-Mode and Harmonic (Contrast) imaging (HI)), M, PWD (Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)), CWD, Color Doppler (Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)), Combined Modes (Includes B+M, B+M+CM, M +CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)), Color M-Mode (CM), 3D/4D, CEUS (Contrast agent for Liver), ARFI, 2D SWI, Freehand tissue elasticity, CEUS (Contrast agent for LVO).

Source page: https://510kreport.com/device/K251820
Methodology: https://510kreport.com/methodology