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Fuji Speed Suite, Fuji Speed Sute Phase II

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

510(k) K013218

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Abbreviated NumberK013218 Date20 Dec 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0993-04 FDA Unclassified (pre-2012) initiated 5 May 2004

    Software: Incorrect measurement of objects within a CR image

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  • Withdrawn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
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Speed Suite, Fuji Speed Sute Phase II is a Solid State X-Ray Imager, also known as a Flat Panel/Digital Imager, used in radiology. It integrates existing Fuji computed radiography image readers and workstations with Siemens radiographic hardware. The system utilizes X-CON software and hardware to interface with workstations and generators.

The device is supplied as a stationary x-ray system, classified as a Class II device, with a product code of MQB and regulated under 21 CFR 892.1680. It has received FDA 510(k) clearance, with the assigned k number being K013218. The device is used in radiology and is manufactured by Fujifilm Medical System U.S.A., Inc.

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

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Questions

AI-generated answers, 25 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 Speed Suite used for?

    The Fuji Speed Suite is used in radiology to integrate existing Fuji computed radiography image readers and workstations with Siemens radiographic hardware.

  • Is the Fuji Speed Suite a single-use or reusable device?

    The device is supplied as a stationary x-ray system, but its reusability is not specified.

  • What regulatory classification does the Fuji Speed Suite have?

    The Fuji Speed Suite is classified as a Class II device, regulated under 21 CFR 892.1680, and has received FDA 510(k) clearance.