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Fuji Medical Laser Imager Fl-Im D

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

510(k) K945475

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 NumberK945475 Date9 Mar 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  • Withdrawn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, 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.

The Fuji Medical Laser Imager Fl-Im D is a camera, multi-format, radiological device. It is a medical device used in the field of radiology. The device is classified as a class 2 device.

The Fuji Medical Laser Imager Fl-Im D is supplied by Fujifilm Medical System U.S.A., Inc. It has been granted FDA 510K clearance with the clearance number K945475. The device is used in a medical setting and is regulated by the FDA with the regulation number 892.2040.

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, 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 Fuji Medical Laser Imager FL-IM D used for?

    The Fuji Medical Laser Imager FL-IM D is used in the field of radiology as a medical device, specifically as a camera for multi-format radiological imaging.

  • Is the Fuji Medical Laser Imager FL-IM D 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 2 device and is used in a medical setting.

  • What regulatory clearance has the Fuji Medical Laser Imager FL-IM D received?

    The Fuji Medical Laser Imager FL-IM D has been granted FDA 510K clearance with the clearance number K945475, regulated by the FDA under regulation number 892.2040.

  • Who is the manufacturer of the Fuji Medical Laser Imager FL-IM D?

    The Fuji Medical Laser Imager FL-IM D is supplied by Fujifilm Medical System U.S.A., Inc.