AI 5200 Ultrasound Transducer
510(k) K883845
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883845 | Date3 Feb 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Resubmitted Ai 5200 Ultrasound Transducer
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AI 5200 Ultrasound Transducer is a diagnostic device classified as an echocardiograph transducer, designed for cardiac ultrasound imaging. It generates high-frequency sound waves to create real-time visual images of the heart’s structures, enabling assessment of cardiac function, chamber size, wall motion, and valvular activity.
This device is supplied as a reusable component for integration into an ultrasound system and is intended for use in clinical settings such as hospitals and cardiology clinics. It adheres to FDA 510(k) clearance (K883845) under the Cardiovascular advisory committee, with a regulatory classification of Class II (870.2330). No specific sterility or MRI safety details are provided in the available data.
Other devices from Phoenix Imaging
Questions
AI-generated answers, 19 Sep 2026
What clinical applications is the AI 5200 Ultrasound Transducer primarily used for in cardiac imaging?
The AI 5200 Ultrasound Transducer is specifically designed for echocardiographic imaging, allowing clinicians to visualize the heart’s structures in real-time. It enables assessment of cardiac function, including chamber size, wall motion abnormalities, and valvular activity, which are critical for diagnosing and monitoring conditions like heart disease, valve disorders, and structural heart defects.
Is the AI 5200 Ultrasound Transducer intended for single-use or reusable in clinical settings?
The AI 5200 Ultrasound Transducer is supplied as a reusable component for integration into an ultrasound system. It is intended for use in clinical environments like hospitals and cardiology clinics, where it can be cleaned and reused across multiple patients, provided proper maintenance protocols are followed.
How is the AI 5200 Ultrasound Transducer regulated, and what does its classification mean for healthcare providers?
The AI 5200 Ultrasound Transducer holds FDA 510(k) clearance (K883845) under the Cardiovascular advisory committee, classified as Class II (870.2330). This means it has been deemed substantially equivalent to a legally marketed predicate device and meets established performance standards for echocardiographic transducers, ensuring its safety and effectiveness for cardiac imaging in regulated clinical settings.
What types of ultrasound systems is the AI 5200 Ultrasound Transducer compatible with?
The AI 5200 Ultrasound Transducer is designed as a reusable component for integration into ultrasound systems that support echocardiographic imaging. While the exact compatibility depends on the manufacturer’s specifications of the host system, it is intended for use with standard ultrasound platforms commonly found in hospitals and cardiology clinics for cardiac evaluations.