Skip to content

Acuson Model X300 Diagnostic Ultrasound System

by Siemens Medi Cal Solutions, Inc.

510(k) K093531

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 NumberK093531 Date1 Dec 2009ClearedStatusActive

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  • Withdrawn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 Acuson Model X300 Diagnostic Ultrasound System is a diagnostic ultrasound device. It is classified as a System, Imaging, Pulsed Doppler, Ultrasonic device within the IYN classification, which covers pulsed Doppler and ultrasound imaging systems. This device is used for medical imaging and provides details on imaging capabilities, clinical performance, workflow efficiency, ergonomics, and connectivity.

The Acuson Model X300 Diagnostic Ultrasound System is supplied as a complete system and is intended for use in medical settings. It has been cleared under the FDA 510(k) clearance, with the clearance number K093531. The device is classified as a Class II device with special controls. It is available in a portable configuration, as described in the user and reference manual.

Other devices from Siemens Medi Cal Solutions, Inc.

See all devices from Siemens Medi Cal Solutions, Inc. →

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 Acuson X300 used for?

    The Acuson X300 is used for medical imaging, providing details on imaging capabilities, clinical performance, workflow efficiency, ergonomics, and connectivity.

  • Is the Acuson X300 portable?

    Yes, the Acuson X300 is available in a portable configuration, as described in the user and reference manual.

  • What is the regulatory status of the Acuson X300?

    The Acuson X300 has been cleared under the FDA 510(k) clearance, with the clearance number K093531, and is classified as a Class II device with special controls.