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Added filter DR-XD 1000 FILTER E

by Fujifilm Corporation

Ref 04547410339215

Added filter DR-XD 1000 FILTER E is a device classified as Class I in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 454741010100000000000623N), cleared under FDA 510(k) K170858 on 24 Apr 2017 and listed in FDA GUDID since 30 Jun 2017 (UDI-DI 04547410339215), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170858

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741010100000000000623N Basic UDI-DI 04547410339215UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410339215 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170858 Date24 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741010100000000000623N registered 2 Jul 2026 Active
  • FDA 510(k) K170858 decided 24 Apr 2017 Active
  • FDA GUDID UDI-DI 04547410339215 listed 30 Jun 2017 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-3158-2024 FDA Class II initiated 23 Nov 2023

    When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

    • Ongoing Z-1470-2023 FDA Class II initiated 27 Feb 2023

    Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.

Timeline

5 dated events

  1. Cleared FDA 510(k) K170858
  2. Listed FDA GUDID 04547410339215
  3. Recall initiated FDA recalls Z-1470-2023
  4. Recall initiated FDA recalls Z-3158-2024
  5. Registered EUDAMED 454741010100000000000623N

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
603Y130021 EUDAMED
Added filter GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
04547410339215 EUDAMED
DR-XD 1000 FILTER E GUDID
Primary DI / UDI-DI
04547410339215
Basic UDI-DI
454741010100000000000623N
510(k) Number
FDA product code
IZL
EMDN code
Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1720
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410339215
GUDID
DR-XD 1000 FILTER E
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Mobile basic diagnostic x-ray system, digital

Cleared under the same submission (K170858)

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)