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Somatom Respiratory Gating

by Siemens Medical Solutions USA, Inc.

510(k) K043086

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 NumberK043086 Date23 Dec 2004ClearedStatusActive

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  • Withdrawn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, 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.

The Somatom Respiratory Gating is a computed tomography (CT) x-ray system designed for respiratory motion management. It synchronizes imaging with patient respiration to reduce artifacts and improve diagnostic accuracy in thoracic and abdominal scans, particularly for patients with irregular breathing patterns.

This device is used in radiology settings and is supplied as a reusable component integrated into CT scanners. It was cleared under FDA 510(k) (K043086) in 2004, adhering to 21 CFR 872.1750. No third-party review was required, and it is intended for use with Siemens CT systems to enhance image quality during respiratory motion.

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