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MULTIX Impact C

by Siemens Medical Solutions USA, Inc.

510(k) K203340

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 NumberK203340 Date6 Jan 2021ClearedStatusActive

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  • Withdrawn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
KPR
Device class
Class II
Regulation
21 CFR Part 892.1680
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.

The MULTIX Impact C is a stationary X-ray system designed for radiology applications. It is a ceiling-mounted radiography system with advanced design and integrated intelligence to assist the user.

The device is supplied as a stationary system for use in clinical settings. It has received FDA 510(k) clearance under K203340 and is classified as a Class II device. The system is manufactured by Siemens Medical Solutions USA, Inc. and is intended for use in radiology environments.

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Questions

AI-generated answers, 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.

  • What is the MULTIX Impact C used for?

    The MULTIX Impact C is designed for radiology applications as a stationary X-ray system. It is intended for use in clinical settings to perform radiographic imaging, leveraging its ceiling-mounted configuration and integrated intelligence to assist users during procedures.

  • How is the MULTIX Impact C supplied and installed?

    The MULTIX Impact C is supplied as a stationary system meant for installation in clinical environments. It is specifically designed as a ceiling-mounted radiography system, requiring fixed installation rather than being portable or mobile.

  • Is the MULTIX Impact C a reusable system or intended for single use?

    The MULTIX Impact C is a stationary X-ray system designed for repeated use in clinical settings. As a fixed installation device, it is not single-use but rather built for long-term operation, requiring routine maintenance and calibration to ensure consistent performance.

  • What regulatory pathway was used for the MULTIX Impact C?

    The MULTIX Impact C received FDA 510(k) clearance under submission number K203340, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance confirms its regulatory pathway as a traditional 510(k) submission for a Class II medical device.

  • What classifies the MULTIX Impact C as a Class II device?

    The MULTIX Impact C is classified as a Class II device based on its product code KPR and regulation number 892.1680, which governs stationary X-ray systems. This classification reflects its moderate risk level, requiring special controls such as performance standards and post-market surveillance to ensure safety and effectiveness.