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Syngo.CT Colonography

by Siemens Medical Solutions USA, Inc.

510(k) K140920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140920 Date3 Dec 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NWE
Device class
Class II
Regulation
21 CFR Part 892.2050
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.

Syngo.CT Colonography is a software module dedicated to noninvasive evaluation of the entire colon based on low-dose, high-resolution spiral CT scans. It is a colon computed tomography system with computer aided detection functionality.

The device is supplied as a software module for use in radiology settings. It has received FDA 510(k) clearance (K140920) and is classified as a Class II device under regulation number 892.2050.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of Syngo.CT Colonography in clinical practice?

    Syngo.CT Colonography is designed for noninvasive evaluation of the entire colon using low-dose, high-resolution spiral CT scans. It combines imaging with computer-aided detection to assist radiologists in identifying abnormalities within the colon without requiring traditional colonoscopy procedures.

  • How is Syngo.CT Colonography supplied and where would it typically be used?

    Syngo.CT Colonography is supplied as a software module, meaning it integrates with existing CT imaging systems rather than being a standalone device. It is intended for use in radiology settings, where it can be deployed alongside CT scanners to enhance diagnostic capabilities for colon assessments.

  • Is Syngo.CT Colonography intended for single-use or repeated use in a clinical setting?

    Since Syngo.CT Colonography is a software module, it is not designed for single-use or disposal. Instead, it is installed on compatible CT systems and can be reused repeatedly across multiple patient evaluations, provided the underlying hardware and system meet the manufacturer’s requirements.

  • What regulatory pathway was followed for FDA clearance of this device?

    Syngo.CT Colonography received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent to a predicate device. The clearance (K140920) was granted under the Radiology advisory committee (RA) and falls under regulation number 892.2050, confirming its status as a Class II medical device.