Vinno 6pro, Vinno 6exp, Vinno 5pro, Vinno 5exp, Vinno 3, Vinno 3pro, Vinno 3exp
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221911 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 VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, and VINNO 3EXP are portable ultrasound imaging systems designed for diagnostic radiology applications. These devices generate real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.
These systems are supplied as reusable medical devices and are intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient facilities. They comply with FDA 510(k) clearance under Special Review (K221911) and EU MDR authorisation, with non-clinical testing confirming safety, effectiveness, and performance equivalence to predicate devices. No specific sterility or MRI safety classifications are noted in the regulatory submissions.
Frequently asked questions
Are these ultrasound systems designed for single-use or can they be reused in a clinical setting?
The VINNO ultrasound systems (6PRO, 6EXP, 5PRO, 5EXP, 3, 3PRO, and 3EXP) are explicitly labeled as reusable medical devices for clinical use in hospitals, diagnostic centers, and outpatient facilities. Since they are not described as sterile or single-use, they require proper cleaning, disinfection, and maintenance between patient encounters to ensure safety and performance.
What types of clinical environments are these devices intended for, and how portable are they?
These portable ultrasound systems are designed for diagnostic radiology applications in settings like hospitals, diagnostic centers, and outpatient facilities. Their portability allows for use in various locations within these environments, though specific weight or mobility features (e.g., battery life, carry case dimensions) are not detailed in the provided data.
How do I know if these devices meet regulatory standards for safety and performance?
The VINNO systems have received FDA 510(k) clearance under Special Review (K221911) and EU MDR authorization, with non-clinical testing confirming safety, effectiveness, and performance equivalence to predicate devices. The Radiology Advisory Committee (RA) reviewed the submission, and the decision was classified as *Substantially Equivalent* (SESE), indicating compliance with regulatory expectations for diagnostic ultrasound devices.
What distinguishes the different models (e.g., VINNO 6PRO vs. VINNO 3EXP) in terms of capabilities?
While the exact technical differences (e.g., resolution, probe types, or software features) between models like the 6PRO/6EXP and 3EXP aren’t specified in the data, the numbering suggests variations in performance or functionality—likely tied to resolution, imaging depth, or connectivity options. The ‘PRO’ and ‘EXP’ suffixes may imply professional-grade or expanded features, but precise distinctions require consulting the manufacturer’s technical documentation.
Do these devices require any special handling or storage conditions?
The data does not specify storage requirements beyond standard environmental conditions for electronic medical devices. Since they are reusable, they should be stored in a clean, dry, and protected environment (e.g., away from extreme temperatures or humidity) to prevent damage. If used in MRI environments, additional safety assessments would be needed, though no MRI compatibility is noted in the submissions.
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. Sources consulted: Vinno 6pro, Vinno 6exp, Vinno 5pro, Vinno 5exp, Vinno 3, Vinno 3pro ..., PDF K221911 - Vinno 6pro, Vinno 6exp, Vinno 5pro, Vinno 5exp, Vinno 3 ..., PDF December 21, 2022 VINNO Technology (Suzhou) Co., Ltd. Cordelia Liu ...
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 | K221911 | Class II | Active |
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Manufacturer
- Manufacturer
- Vinno Technology (Suzhou) Co., Ltd
- FDA Applicant
- Vinno Technology (Suzhou) Co.,Ltd
Sources (2)
- FDA 510(k) K221911 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026