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Fuji Computed Radiography System FCR AC-1 (FCR)

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

510(k) K896050

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 NumberK896050 Date14 Dec 1989ClearedStatusActive

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  • Withdrawn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, 6 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 is a Fuji Computed Radiography System FCR AC-1 (FCR), a Class II X-ray system used in radiology. It is a computed radiography system designed for imaging applications.

The device was cleared by the FDA through the 510(k) process under K896050, with a decision date of December 14, 1989. It is manufactured by Fujifilm Medical System U.S.A., Inc. and is intended for use in radiology settings.

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, 6 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 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) used for?

    This device is a computed radiography system designed for imaging applications in radiology settings, used to capture and process X-ray images for diagnostic purposes.

  • How was the FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) authorized for market?

    The device was cleared by the FDA through the 510(k) process under submission K896050, with a decision of substantially equivalent granted on December 14, 1989, based on its traditional clearance pathway.

  • Who manufactures the FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) and where is it located?

    Fujifilm Medical System U.S.A., Inc. manufactures this system, with its address listed as 90 Viaduct Rd., P.O. Box 4960, Stamford, CT 06907, United States.