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Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

by Toshibamedical Systems Corporation

510(k) K173090

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 NumberK173090 Date11 Jan 2018ClearedStatusActive

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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 is a diagnostic ultrasound system. It is used for the visualization of internal structures. The system consists of multiple models, including the Aplio i900, i800, i700, and i600. It provides diagnostic imaging capabilities.

The system is supplied with various features and is intended for use in a clinical setting. It has been authorized with an FDA 510K clearance. The system is available in different models, including the TUS-AI900, TUS-AI800, TUS-AI700, and TUS-AI600. It is used for diagnostic purposes, providing sharper imaging and smarter automation.

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Questions

AI-generated answers, 27 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 Aplio Diagnostic Ultrasound System used for?

    The Aplio Diagnostic Ultrasound System is used for the visualization of internal structures and provides diagnostic imaging capabilities in a clinical setting.

  • What models are available in the Aplio Diagnostic Ultrasound System?

    The system is available in different models, including the Aplio i900, i800, i700, and i600, also referred to as TUS-AI900, TUS-AI800, TUS-AI700, and TUS-AI600.

  • Is the Aplio Diagnostic Ultrasound System authorized for use?

    Yes, the system has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.

  • What features does the Aplio Diagnostic Ultrasound System provide?

    The system provides sharper imaging and smarter automation, along with various other features for diagnostic purposes.