ZS3 Ultrasound System, z.one Pro Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171891 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ZS3 Ultrasound System and z.one Pro Ultrasound System are portable diagnostic imaging devices designed for real-time ultrasound imaging. These systems utilise high-frequency sound waves to generate images of internal body structures, aiding in the evaluation of organs, tissues, and blood flow for diagnostic purposes.
These systems are supplied by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and are intended for use in clinical settings such as hospitals, diagnostic centres, and emergency departments. The devices are classified under product code IYN and have received FDA 510K clearance and MDR authorisation, ensuring compliance with regulatory standards. They are designed for single-use or reusable applications depending on the configuration and accessories used, though specific sterility and reuse instructions must follow manufacturer guidelines.
Frequently asked questions
What types of clinical environments is the ZS3 Ultrasound System or z.one Pro Ultrasound System intended for use in?
These systems are designed for use in clinical settings such as hospitals, diagnostic centers, and emergency departments. Their portable design makes them suitable for environments where mobility and real-time imaging are essential, such as point-of-care diagnostics or field settings where traditional ultrasound machines may not be practical.
Are the ZS3 Ultrasound System and z.one Pro Ultrasound System intended for single-use or reusable applications?
The systems themselves are not inherently single-use or reusable—their intended use depends on the specific configuration and accessories applied. For example, probes or transducers may be single-use or reusable based on manufacturer guidelines. Always follow the manufacturer’s instructions for sterility and reuse to ensure safe and compliant use.
How do I know if these devices comply with regulatory standards?
Both the ZS3 Ultrasound System and z.one Pro Ultrasound System have received FDA 510(k) clearance and MDR authorization, confirming compliance with U.S. and European regulatory requirements. The FDA clearance was granted under the Radiology advisory committee, and the device was determined to be substantially equivalent to a predicate. Always verify the latest regulatory status with the manufacturer or official databases.
What is the primary purpose of these ultrasound systems in medical diagnostics?
These systems use high-frequency sound waves to create real-time images of internal body structures, including organs, tissues, and blood flow. This aids clinicians in evaluating anatomical features and diagnosing conditions such as organ abnormalities, vascular issues, or soft tissue injuries during procedures like examinations or emergency assessments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171891 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K171891 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026