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Syngo Ct Dynamic Angio

by Siemens AG Medical Solutions

510(k) K120331

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 NumberK120331 Date13 Apr 2012ClearedStatusActive

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  • Withdrawn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, 21 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 Dynamic Angio is a device designed to perform dynamic vessel evaluation by visualizing the flow of contrast from the arteries to the veins, and allows for the visual inspection of time attenuation curves. It is used to inspect diseases that affect the vessel system, such as vascular malformations. The device is an accessory to a computed tomography system. It is classified as a Class II device under 21 CFR §892.1750. The device is used in radiology applications.

The Syngo Ct Dynamic Angio is supplied as an accessory to a computed tomography system and is intended for use in a clinical setting. The device has been authorized under FDA 510K with the clearance type being Traditional and the k number being K120331. The device is classified under product code JAK. It is a reusable device and is not specified as sterile or single-use. The device is stored at the manufacturer's address in Erlangen, Germany.

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