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Fuji Computed Radiograp Hi-C654 Dms Crt Image Cons

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

510(k) K931002

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931002 Date8 Jun 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IXK
Device Class
Class II
Regulation
21 CFR Part 892.1630
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

This device is a System, Imaging, X-Ray, Electrostatic, as defined in the nomenclature authority. It is designed to receive, process, display, and transmit medical images.

It is supplied as a multimodality display system for networks and is authorized under FDA 510(k) clearance K931002. The device is classified as FDA class 2, with regulation number 892.1630 and product code IXK, and is intended for use in radiology.

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Questions

AI-generated answers, 24 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 COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS used for?

    It is designed to receive, process, display, and transmit medical images as a System, Imaging, X-Ray, Electrostatic, intended for use in radiology to support diagnostic workflows via networked multimodality display.

  • How is the FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS supplied and authorized?

    It is supplied as a multimodality display system for networks and has FDA 510(k) clearance under K931002, classified as FDA class 2 with product code IXK and regulation number 892.1630.

  • What regulatory pathway and classification apply to the FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS?

    The device follows the Traditional 510(k) pathway, was found Substantially Equivalent (SESE), and is classified as FDA class 2 under product code IXK for radiographic imaging systems.