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syngo. CT Single Source Dual Energy (twin beam)

by Siemens Medical Solutions USA, Inc., Ultrasound DI

510(k) K163289

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 NumberK163289 Date9 Feb 2017ClearedStatusActive

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 syngo. CT Single Source Dual Energy (twin beam) is a software application designed for dual-energy imaging with a single-source CT scanner. It enables simultaneous acquisition of high and low kV datasets in a single spectral CT scan by splitting the X-ray beam with two filters before it reaches the patient. This technology allows for enhanced tissue characterization and optimized patient care in high-contrast dynamic applications.

The device is supplied as software for CT imaging systems and is intended for use in radiology departments. It is not specified as single-use or reusable, and no information regarding sterility or MRI safety is provided. The device is authorized under FDA 510(k) clearance with number K163289 and product code JAK, having been determined substantially equivalent to predicate devices.

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Questions

AI-generated answers, 22 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 syngo. CT Single Source Dual Energy (twin beam) software used for?

    This software application is designed for dual-energy imaging with single-source CT scanners, enabling simultaneous acquisition of high and low kV datasets in a single spectral CT scan by splitting the X-ray beam with two filters before it reaches the patient.

  • How is the syngo. CT Single Source Dual Energy software supplied?

    The device is supplied as software for CT imaging systems and is intended for use in radiology departments. No information is provided regarding sterility or MRI safety.

  • What is the regulatory status of this software?

    The device is authorized under FDA 510(k) clearance with number K163289 and product code JAK, having been determined substantially equivalent to predicate devices.

  • What clinical applications benefit from this dual-energy imaging software?

    This technology allows for enhanced tissue characterization and optimized patient care in high-contrast dynamic applications, providing improved diagnostic capabilities in radiology departments.