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Nemio

by Toshiba America Medical Systems, In.C

510(k) K010631

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 NumberK010631 Date15 Mar 2001ClearedStatusActive

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  • Withdrawn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, 24 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 Nemio is a diagnostic ultrasound system designed for medical imaging applications. It functions by utilizing ultrasound technology to capture internal images for clinical evaluation.

This device has received FDA 510(k) clearance. It is categorized under product code IYN and is associated with the radiology advisory committee.

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Questions

AI-generated answers, 24 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 function of the Nemio ultrasound system?

    The Nemio is a diagnostic ultrasound system engineered for medical imaging applications. It utilizes ultrasound technology to capture internal images, which are then used by clinicians for diagnostic evaluation.

  • What is the regulatory status of the Nemio system?

    The Nemio system has received FDA 510(k) clearance. It is classified under product code IYN and is associated with the radiology advisory committee, confirming it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of the Nemio device?

    The Nemio diagnostic ultrasound system is manufactured by Toshiba America Medical Systems, Inc., located in Tustin, California.