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Ultrasound Scanner XL

by Interad Systems, Inc.

510(k) K834307

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 NumberK834307 Date21 Feb 1984ClearedStatusActive

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  • Withdrawn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.

The Ultrasound Scanner XL is a diagnostic imaging device classified as an ultrasound scanner, designed to produce real-time visual images of internal body structures using high-frequency sound waves. It is intended for medical professionals to evaluate organs, tissues, and other anatomical features for diagnostic purposes, particularly in radiology settings.

This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under product code IYO, with a clearance date of February 21, 1984. It is intended for use in clinical environments where ultrasound imaging is required, adhering to regulatory standards established by the FDA. No specific sterility or MRI safety information is provided in the available data.

Other devices from Interad Systems, Inc.

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 types of medical settings is the Ultrasound Scanner XL intended for use in?

    The Ultrasound Scanner XL is designed for clinical environments where ultrasound imaging is required, specifically in radiology settings. Its primary purpose is to assist medical professionals in evaluating internal body structures like organs and tissues for diagnostic purposes.

  • Is the Ultrasound Scanner XL a single-use or reusable device?

    The Ultrasound Scanner XL is supplied as a reusable medical instrument. This means it is intended to be cleaned, disinfected, and reused multiple times under proper clinical protocols.

  • What regulatory pathway did the Ultrasound Scanner XL follow to gain clearance?

    The Ultrasound Scanner XL received FDA 510(k) clearance under the traditional review pathway, determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted by the FDA’s Radiology Advisory Committee (RA) on February 21, 1984, under product code IYO.

  • Does the Ultrasound Scanner XL come with any specific sterility guarantees?

    The available data does not specify any sterility requirements or guarantees for the Ultrasound Scanner XL. Since it is a reusable device, proper cleaning and disinfection protocols would be required for clinical use.

  • Who is the manufacturer of the Ultrasound Scanner XL, and where is it based?

    The manufacturer of the Ultrasound Scanner XL is Interad Systems, Inc., based at 4221 Richmond Rd., NW, Walker, MI 49534, United States.