5 MHz Transducer
by Sonicaid, Inc. 510(k)
Active
510(k) K872074
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872074 | Date25 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JOP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2880
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an Ultrasonic Transducer, classified under the FDA’s product code JOP for cardiovascular applications. It operates at a frequency of 5 MHz, designed for use in Doppler ultrasound systems to detect and measure blood flow and cardiac activity. The transducer emits and receives ultrasonic waves, enabling real-time assessment of hemodynamic parameters in clinical settings. Its design aligns with regulatory definitions for non-invasive diagnostic cardiovascular devices.
The 5 MHz Transducer is supplied as a reusable component intended for integration into Doppler ultrasound equipment, such as fetal or cardiovascular monitors. It is not sterile and requires cleaning and maintenance per manufacturer guidelines to ensure proper function and hygiene. The device is regulated under FDA’s 510(k) clearance (K872074) as a Class II medical device, with no explicit MRI safety labeling provided. Storage conditions are unspecified but should follow standard practices for ultrasound transducers to prevent damage. Authorisation was granted through the Traditional 510(k) pathway in 1987.
Other devices from Sonicaid, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the 5 MHz Transducer used for in clinical settings?
The 5 MHz Transducer is specifically designed for Doppler ultrasound systems to detect and measure blood flow and cardiac activity. It enables real-time assessment of hemodynamic parameters, making it particularly useful in cardiovascular applications, such as fetal or heart monitoring. Its high-frequency operation allows for precise imaging of blood flow dynamics, which is critical for diagnosing and evaluating cardiac function.
Is the 5 MHz Transducer single-use or reusable?
The 5 MHz Transducer is supplied as a reusable component. It is intended for integration into Doppler ultrasound equipment and requires regular cleaning and maintenance to ensure proper function and hygiene. Reusability is common for ultrasound transducers when used in controlled clinical environments with appropriate disinfection protocols.
What are the storage requirements for the 5 MHz Transducer?
While specific storage conditions are not detailed in the provided data, standard practices for ultrasound transducers should be followed to prevent damage. This typically includes storing the transducer in a clean, dry environment away from direct sunlight, extreme temperatures, and physical impacts. Proper storage ensures longevity and maintains the transducer’s performance for accurate diagnostic use.
How is the sterility of the 5 MHz Transducer handled?
The 5 MHz Transducer is explicitly noted as non-sterile. Since it is a reusable component, it must be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination. Sterility is not applicable for reusable devices, as they are intended to be disinfected between uses rather than disposed of after single use.
What regulatory pathway was followed for the FDA clearance of this device?
The 5 MHz Transducer received FDA clearance through the Traditional 510(k) pathway, granted on August 25, 1987. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness as a Class II medical device under product code JOP for cardiovascular applications.