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Acuson I5100 Ultrasound Transducer

by Acuson Corp.

510(k) K884632

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK884632 Date13 Jan 1989ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0864-03 FDA Unclassified (pre-2012) initiated 31 Mar 2003 on shared 510(k) K884632
    • Terminated Z-0865-03 FDA Unclassified (pre-2012) initiated 31 Mar 2003 on shared 510(k) K884632

    The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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 Acuson I5100 Ultrasound Transducer is a System, Imaging, Pulsed Echo, Ultrasonic device designed for diagnostic radiology. It generates high-frequency sound waves to create real-time images of internal body structures, aiding in the evaluation of organs, tissues, and vascular systems for clinical assessment.

This transducer is supplied as part of a Class II ultrasound system and is intended for use in radiology settings. It was cleared under FDA 510(k) K884632 in 1989, with a decision of Substantially Equivalent (SESE). No third-party review was conducted, and its regulatory classification aligns with the Product Code IYO under the Radiology specialty.

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