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Maxilim

by Medicim NV

510(k) K052424

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 NumberK052424 Date31 Mar 2006ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Maxilim is a medical imaging system used in radiology. It is a digital radiography equipment designed for imaging purposes.

The device received FDA 510(k) clearance under K052424 on March 31, 2006, and is classified as substantially equivalent. It is manufactured by Medicim NV and supplied as a non-sterile, reusable system for use in clinical imaging settings.

Questions

AI-generated answers, 26 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 Maxilim system used for?

    The Maxilim system is a medical imaging system used in radiology, specifically designed as digital radiography equipment for imaging purposes in clinical settings.

  • Is the Maxilim system sterile or non-sterile, and is it single-use or reusable?

    The Maxilim system is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and reprocessing in clinical imaging environments.

  • When did the Maxilim system receive FDA clearance and under what submission number?

    The Maxilim system received FDA 510(k) clearance on March 31, 2006, under submission number K052424, and was determined to be substantially equivalent to a predicate device.