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Ultrasound

by Toshiba Medical Systems

510(k) K771600

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771600 Date22 Sep 1977ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Ultrasound is a medical imaging device that uses high-frequency sound waves to produce images of internal body structures. It is designed for diagnostic imaging applications in various medical settings.

The device is supplied by Toshiba Medical Systems and is authorized under FDA 510K clearance with product code IYO. It is available in multiple models and configurations for different clinical applications, with specific details regarding sterility, single-use or reusable status, and MRI safety not specified in the provided data.

Other devices from Toshiba Medical Systems

See all devices from Toshiba Medical Systems →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the ULTRASOUND device?

    The ULTRASOUND device is a medical imaging device that uses high-frequency sound waves to produce images of internal body structures for diagnostic imaging applications in various medical settings.

  • Is the ULTRASOUND device single-use or reusable?

    The provided data does not specify whether the ULTRASOUND device is single-use or reusable, as this information is not included in the device description.

  • What models and configurations are available for the ULTRASOUND device?

    The ULTRASOUND device is available in multiple models and configurations for different clinical applications, though specific model details are not provided in the device data.

  • What is the regulatory status of the ULTRASOUND device?

    The ULTRASOUND device is authorized under FDA 510K clearance with product code IYO, which means it has been determined to be substantially equivalent to existing devices.

  • Is the ULTRASOUND device supplied sterile?

    The provided data does not specify whether the ULTRASOUND device is supplied sterile, as this information is not included in the device description.