Skip to content

Sound Imager I

by Sound Imaging, Inc.

510(k) K833231

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 NumberK833231 Date4 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  • Withdrawn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, 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 Sound Imager I is a diagnostic imaging device. It is designed to function within the field of radiology.

This device is identified by K-number K833231 and has received FDA 510k clearance. It is manufactured by Sound Imaging, Inc. based in Mchenry, Illinois.

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 primary function of the Sound Imager I?

    The Sound Imager I is a diagnostic imaging device specifically designed to function within the field of radiology to assist clinicians in medical imaging procedures.

  • What is the regulatory status of this device?

    The Sound Imager I has received FDA 510k clearance under K-number K833231. This indicates that the device has been found to be substantially equivalent to other legally marketed predicate devices.

  • Who is the manufacturer of the Sound Imager I?

    The device is manufactured by Sound Imaging, Inc., which is located in Mchenry, Illinois. They are the official applicant for the device's regulatory clearance.