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Wireless Portable Detector FD-W17

by Philips Medical Systems North America Co.

510(k) K090625

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

28 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 · Traditional NumberK090625 Date24 Mar 2009ClearedStatusActive

Recalls

28 recalls · FDA

  • 28 recalls, same reason

    • Terminated Z-2843-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2867-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2851-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2849-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2862-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2848-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2866-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2865-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2850-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2858-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2863-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2847-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2841-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2856-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2855-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2861-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2857-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2864-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2844-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2845-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2868-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2859-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2860-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2846-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2842-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2853-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2854-2018 FDA Class II initiated 27 Jun 2018
    • Terminated Z-2852-2018 FDA Class II initiated 27 Jun 2018

    The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

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, 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 device is a Solid State X-Ray Imager (Flat Panel/Digital Imager) as defined in the device data. It functions as a digital X-ray receptor component that captures X-ray signals and converts them into digital images for radiographic systems.

It integrates with the Philips XD-S workstation (computer, display, input peripherals) to facilitate image acquisition and processing. The device is intended for use in clinical environments, is classified as Class II, and received FDA 510(k) clearance under K090625 with product code MQB and regulation number 892.1680.

Other devices from Philips Medical Systems North America, Inc.

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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 WIRELESS PORTABLE DETECTOR FD-W17 used for?

    The WIRELESS PORTABLE DETECTOR FD-W17 functions as a digital X-ray receptor component that captures X-ray signals and converts them into digital images for use in radiographic systems, enabling image acquisition and processing when integrated with the Philips XD-S workstation in clinical environments.

  • How is the WIRELESS PORTABLE DETECTOR FD-W17 supplied and integrated into a system?

    The device is supplied as a standalone Solid State X-Ray Imager (Flat Panel/Digital Imager) designed to integrate with the Philips XD-S workstation, which includes a computer, display, and input peripherals, to facilitate image acquisition and processing in clinical settings.

  • Is the WIRELESS PORTABLE DETECTOR FD-W17 intended for single-use or reuse?

    The device data does not specify whether the WIRELESS PORTABLE DETECTOR FD-W17 is single-use or reusable; however, as a Solid State X-Ray Imager designed for integration with a workstation in clinical environments, it is intended for repeated use as a durable component of a radiographic system.