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Computerized Tomography X-Ray System Option

by Siemens Medical Solutions USA, Inc. 3 variants

510(k) K924985

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924985 Date7 Apr 1994ClearedStatusActive

Official records

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Computerized Tomography X-Ray System Option, designed as an add-on or upgrade component for existing CT scanners to enhance imaging capabilities. It operates by generating cross-sectional X-ray images of the body, enabling detailed visualization of internal structures for diagnostic purposes. The system is intended for use in radiology departments and clinical settings where advanced imaging is required. Its functionality aligns with the broader category of CT scanner accessories, providing supplementary features to improve diagnostic accuracy and efficiency.

The system is supplied as a standalone option for integration with compatible CT scanners and is regulated under FDA 510(k) clearance (K924985) as a substantially equivalent device. It is not described as single-use or reusable in the provided data, nor are specific sterility or MRI safety details mentioned. The device is intended for use in radiology settings and adheres to regulatory standards as outlined in the 510(k) submission. No additional specifications regarding storage, sizing, or other operational details are provided in the available data.

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