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Fcr Fuji Computed Radiography Dms Crt Image Console HI-C654

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

510(k) K972256

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 NumberK972256 Date12 Sep 1997ClearedStatusActive

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  • Withdrawn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)

Full name
Fcr Fuji Computed Radiography Dms Crt Image Console Hi-C654 (for Networks)
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, 22 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 FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 is a multimodality display system designed for networks. It is used to receive, process, display, and transmit medical images.

This device is classified as a system for radiological image processing. It received FDA 510(k) clearance under K972256.

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