PVK-720ST Endocavitary Transducer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964865 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Toshiba America Medical Systems, In.C →

• What types of internal organs or cavities can the PVK-720ST Endocavitary Transducer be used to image, and how does it achieve this?

  The PVK-720ST Endocavitary Transducer is specifically designed for internal imaging of hollow organs and cavities such as the bladder, uterus, or rectum. It achieves this by emitting high-frequency sound waves that bounce off internal structures, creating real-time visualizations on compatible ultrasound systems like the SSA-380A. This allows clinicians to assess anatomical details and potential abnormalities within these cavities.

• Is the PVK-720ST Endocavitary Transducer intended for single-use or reusable applications, and what does this mean for maintenance?

  The PVK-720ST Endocavitary Transducer is supplied as a reusable medical instrument, meaning it is designed to be cleaned, disinfected, and reused multiple times under proper conditions. This requires adherence to strict maintenance protocols, including sterilization procedures, to ensure safety and functionality between uses. Reusability extends the device’s lifespan but demands careful handling to prevent contamination or damage.

• What ultrasound systems is the PVK-720ST Endocavitary Transducer compatible with, and how does this affect its use in clinical settings?

  The PVK-720ST Endocavitary Transducer is explicitly designed for use with compatible ultrasound systems, such as the Toshiba SSA-380A. This compatibility ensures seamless integration, allowing clinicians to leverage the transducer’s imaging capabilities within the system’s software and hardware framework. When selecting equipment for a clinical setting, verifying this compatibility is essential to avoid operational issues or compromised diagnostic performance.

• How was the PVK-720ST Endocavitary Transducer cleared for use in the U.S., and what does this regulatory pathway imply about its safety and effectiveness?

  The PVK-720ST Endocavitary Transducer was cleared by the FDA under the 510(k) pathway in 1997, specifically as substantially equivalent to predicate devices. This pathway demonstrates that the manufacturer has shown the device is as safe and effective as a legally marketed alternative that was not subject to premarket approval. While this does not guarantee absolute safety or efficacy, it indicates that the device meets FDA standards for equivalence to existing, cleared technologies in its category.