Skip to content

Fuji Medical Laser Imagermulti-Formatters Mf-300 and Mf-300l

by Fujifilm Medical System U.S.A., Inc.

510(k) K950721

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 NumberK950721 Date24 May 1995ClearedStatusActive

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  • Withdrawn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
LMC
Device Class
Class II
Regulation
21 CFR Part 892.2040
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Fuji Medical Laser Imager Multi-Formatters Mf-300 And Mf-300l is a Camera, Multi Format, Radiological device. It is classified as a Class II medical device. The device is used in radiology. The Fuji Medical Laser Imager Multi-Formatters Mf-300 And Mf-300l is substantially equivalent to other devices.

The device is supplied by Fujifilm Medical System U.S.A., Inc. It has been cleared under the FDA 510K number K950721. The device is regulated under the regulation number 892.2040. The Fuji Medical Laser Imager Multi-Formatters Mf-300 And Mf-300l has a product code of LMC and is registered with the FDA.

Other devices from Fujifilm Medical System U.S.A., Inc.

See all devices from Fujifilm Medical System U.S.A., Inc. →

Questions

AI-generated answers, 27 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 Fuji Medical Laser Imager used for?

    The Fuji Medical Laser Imager is used in radiology, specifically as a camera, multi format, radiological device.

  • Is the Fuji Medical Laser Imager a single-use or reusable device?

    The device description does not specify whether it is single-use or reusable, but it is classified as a Class II medical device.

  • What is the regulatory status of the Fuji Medical Laser Imager?

    The device has been cleared under the FDA 510K number K950721 and is regulated under the regulation number 892.2040.

  • What are the different models of the Fuji Medical Laser Imager?

    The device is available in two models: MF-300 and MF-300L.