Endovaginal Probe, SMS-510VA

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

510(k) Number

K882959 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the Toshiba SMS-510VA endovaginal probe?

  The Toshiba SMS-510VA is designed specifically for transvaginal ultrasound imaging. It emits high-frequency sound waves to create real-time visual images of pelvic organs, which aids clinicians in diagnosing conditions such as fibroids, cysts, and other gynecological or obstetric abnormalities. Its specialized design allows for closer proximity imaging compared to abdominal probes, improving resolution and diagnostic accuracy.

• Is the Toshiba SMS-510VA probe single-use or reusable?

  The Toshiba SMS-510VA is supplied as a reusable medical instrument. To ensure patient safety and maintain hygiene standards, it must undergo appropriate sterilization between uses in clinical radiology settings. Reusability is common for high-end imaging probes, as they are built to withstand repeated sterilization cycles while maintaining performance.

• What sterilization methods are recommended for the Toshiba SMS-510VA?

  While the provided data does not specify exact sterilization methods, reusable ultrasound probes like the SMS-510VA typically require validation for sterilization techniques such as autoclaving, ethylene oxide gas, or other FDA-cleared methods. The manufacturer’s instructions for use (IFU) should be consulted for precise guidelines, as improper sterilization can compromise device integrity or patient safety.

• What regulatory pathway was followed for FDA clearance of the Toshiba SMS-510VA?

  The Toshiba SMS-510VA received FDA 510(k) clearance under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) issued in 1988. This classification indicates that the device was deemed comparable to legally marketed predicate devices in terms of safety and effectiveness. The product code assigned is IYO, which falls under the Radiology advisory committee.

• How does the Toshiba SMS-510VA improve diagnostic accuracy compared to abdominal probes?

  The SMS-510VA is an endovaginal transducer, meaning it is inserted closer to the pelvic organs than abdominal probes. This proximity reduces sound wave attenuation and improves resolution, allowing for clearer visualization of structures like the uterus, ovaries, and surrounding tissues. This enhanced imaging quality is particularly valuable for detecting small abnormalities or assessing complex cases in gynecology and obstetrics.