BenQ Diagnostic Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181313 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 BenQ Diagnostic Ultrasound System is a Class 2 Radiology device classified under the nomenclature code IYN, designed for diagnostic imaging using pulsed Doppler ultrasonic technology. It functions as an imaging system to visualize internal body structures, blood flow, and organ function through real-time ultrasound scanning. This device supports radiology applications, including vascular studies, obstetrics, and general abdominal imaging, by generating detailed sonographic images.
This system is supplied by Qisda Corporation and is intended for use in clinical settings such as hospitals, diagnostic centers, and radiology departments. It is regulated under FDA 510(k) clearance (K181313) and the European MDR, with a traditional review pathway confirming substantial equivalence to a predicate device. The device is not specified as single-use or reusable, and no MRI safety classification or sterility requirements are noted in the available data. Storage and handling instructions are not provided in the regulatory submissions.
Frequently asked questions
What types of medical imaging studies is the BenQ Diagnostic Ultrasound System primarily used for in clinical practice?
The BenQ Diagnostic Ultrasound System is designed for real-time ultrasound imaging to visualize internal body structures, blood flow, and organ function. It supports radiology applications such as vascular studies, obstetrics, and general abdominal imaging, making it versatile for a range of diagnostic needs in clinical settings like hospitals and radiology departments.
Is the BenQ Diagnostic Ultrasound System intended for single-use or can it be reused in a clinical environment?
The available regulatory data for the BenQ Diagnostic Ultrasound System does not specify whether it is single-use or reusable. Since it is a Class 2 Radiology device supplied for use in clinical settings, its reuse would depend on manufacturer guidelines and facility protocols, which are not detailed in the provided information.
How is the BenQ Diagnostic Ultrasound System regulated, and what does its FDA clearance indicate?
The BenQ Diagnostic Ultrasound System holds an FDA 510(k) clearance under the reference number K181313, granted through a traditional review pathway. This clearance confirms that the device is substantially equivalent to a predicate device already on the market, ensuring it meets applicable safety and performance standards for diagnostic ultrasound imaging.
What are the key specifications or features that define the BenQ Diagnostic Ultrasound System’s functionality?
The BenQ Diagnostic Ultrasound System utilizes pulsed Doppler ultrasonic technology to generate detailed sonographic images for diagnostic purposes. It is classified under product code IYN and is intended for radiology applications, including vascular studies, obstetrics, and abdominal imaging, as outlined in its regulatory 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: K181313 FDA 510 (k) - BenQ Diagnostic Ultrasound System, BenQ Diagnostic Ultrasound System 510(k) K181313 - FDA.report, BenQ – Wikipedia, BenQ Diagnostic Ultrasound System (K181313) — FDA 510(k) | Innolitics
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 | K181313 | Class II | Active |
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Manufacturer
- Manufacturer
- Qisda Corporation
Sources (2)
- FDA 510(k) K181313 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026