Diagnostic Doppler Ultrasound System Curved Linear Array 2-5 Mhz Transducer Linear Array 5-11 Mhz Transducer Phase Arra
by Benq Medical Technology Corpation
510(k) K121983
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121983 | Date7 Sep 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Diagnostic Doppler Ultrasound System designed for vascular and soft-tissue imaging. It incorporates a curved linear array transducer (2-5 MHz) for deeper tissue penetration and a linear array transducer (5-11 MHz) for higher-resolution imaging, along with a phase array transducer for Doppler blood flow assessment. The system enables real-time visualization of blood flow and tissue structures, supporting diagnostic evaluations in radiology settings.
The system is supplied with an integrated preprogrammed color ultrasound imaging system, featuring a 15-inch LCD display and a specialized control keyboard. It operates as a Class II medical device with FDA 510(k) clearance (K121983), classified under the Radiology advisory committee. The device is intended for single-use or reusable applications in clinical diagnostic imaging, with no specific sterility or MRI safety restrictions noted in the data.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Benq Doppler Ultrasound System with curved and linear array transducers?
This system is designed for vascular and soft-tissue diagnostic imaging. The curved linear array (2-5 MHz) provides deeper tissue penetration, ideal for larger anatomical structures like blood vessels, while the linear array (5-11 MHz) delivers higher-resolution images for superficial tissues. The phase array transducer enables Doppler assessment of blood flow, making it suitable for evaluating circulation and tissue perfusion in radiology settings.
How is the Benq Doppler Ultrasound System supplied, and what are its key components?
The system comes as an integrated unit with a preprogrammed color ultrasound imaging system. It includes a 15-inch LCD display for real-time visualization and a specialized control keyboard for operator adjustments. The transducers (curved linear, linear, and phase array) are part of the core hardware, enabling versatile imaging and Doppler functionality without requiring additional accessories.
Is the Benq Doppler Ultrasound System intended for single-use or reusable applications?
The device is classified for both single-use and reusable applications in clinical diagnostic imaging. However, the manufacturer does not specify sterility requirements or MRI safety restrictions in the provided data, so clinicians must follow facility protocols for cleaning, disinfection, and reuse to ensure patient safety and device integrity.
What are the frequency ranges of the transducers included in this system, and how do they differ?
The system includes three transducers: a curved linear array (2-5 MHz) optimized for deeper tissue imaging, a linear array (5-11 MHz) for higher-resolution surface imaging, and a phase array transducer for Doppler blood flow assessment. The lower frequency (2-5 MHz) penetrates deeper but with less detail, while the higher frequency (5-11 MHz) offers finer resolution but limited depth.
What regulatory clearance does the Benq Doppler Ultrasound System hold, and how was it classified?
The device holds FDA 510(k) clearance under the product code IYN, classified as substantially equivalent to a predicate device. It was reviewed by the Radiology Advisory Committee (RA) and granted clearance on September 7, 2012, under the traditional clearance type. This classification aligns with its use as a Class II medical device for diagnostic imaging.