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SOMATOM Definition AS Open (VA48)

by Siemens Medical Solutions USA, Inc.

510(k) K143409

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 NumberK143409 Date26 Mar 2015ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0373-2017 FDA Class II initiated 19 Oct 2016

    Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.

    • Terminated Z-2624-2016 FDA Class II initiated 13 Jul 2016

    Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

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  • Withdrawn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
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 SOMATOM Definition AS Open (VA48) is a computed tomography (CT) scanner system designed for diagnostic imaging. It is a medical device used to produce cross-sectional images of the body using X-ray technology.

This device is supplied as a non-sterile, reusable system intended for use in radiology settings. It operates under traditional 510(k) clearance (K143409) and is authorized for marketing in the United States. The system includes the VA48 software version and is configured as an open-design CT scanner to accommodate various patient needs.

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Questions

AI-generated answers, 25 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 SOMATOM Definition AS Open used for?

    The SOMATOM Definition AS Open is used for diagnostic imaging, producing cross-sectional images of the body using X-ray technology, in radiology settings.

  • Is the SOMATOM Definition AS Open supplied sterile?

    No, the SOMATOM Definition AS Open is supplied as a non-sterile system, but it is reusable.

  • What type of clearance does the SOMATOM Definition AS Open operate under?

    The SOMATOM Definition AS Open operates under traditional 510(k) clearance, with the authorization number K143409.