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APLIO DIAGNOSTIC ULTRASOUND SYSTEM - Aplio Diagnostic Ultrasound System

by Toshiba America Medical Systems, In.C

510(k) K110870

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 NumberK110870 Date4 Oct 2011ClearedStatusActive

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  • Withdrawn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
Models / Variants
Aplio Diagnostic Ultrasound System
Aplio Diagnostic Ultrasound System
Aplio Diagnostic Ultrasound System
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Diagnostic Ultrasound System is a medical imaging device used for diagnostic ultrasound examinations. It integrates imaging technologies and applications to assist clinicians in routine imaging departments.

The system is supplied by Toshiba America Medical Systems and has received FDA 510(k) clearance with K number K110870. It is designed for use in various clinical applications and is regulated under product code IYN.

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Questions

AI-generated answers, 28 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 a medical imaging device used for diagnostic ultrasound examinations. It integrates imaging technologies and applications to assist clinicians in routine imaging departments.

  • What is the regulatory status of the Aplio Diagnostic Ultrasound System?

    The Aplio Diagnostic Ultrasound System has received FDA 510(k) clearance with K number K110870. It is designed for use in various clinical applications and is regulated under product code IYN.

  • Who manufactures the Aplio Diagnostic Ultrasound System?

    The Aplio Diagnostic Ultrasound System is supplied by Toshiba America Medical Systems, which is located in Tustin, California.

  • What advisory committee reviewed the Aplio Diagnostic Ultrasound System?

    The Aplio Diagnostic Ultrasound System was reviewed by the Radiology Advisory Committee (RA) as part of its FDA 510(k) clearance process.