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FDR nano

by FUJIFILM Corporation 2 variants

Ref 04547410489873

FDR nano (04547410489873) is a device classified as Class IIb in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 454741010100000000001323J), cleared under FDA 510(k) K170858 on 24 Apr 2017 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 04547410489873), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04547410489873 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number454741010100000000001323J Basic UDI-DI 04547410489873UDI-DIDate2 Jul 2026RegisteredStatusActive
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 454741010100000000001323J registered 2 Jul 2026 Active
  • FDA 510(k) K170858 decided 24 Apr 2017 Active
  • FDA GUDID UDI-DI 04547410489873 listed 20 Aug 2026 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. Recall initiated FDA recalls Z-1470-2023
  3. Recall initiated FDA recalls Z-3158-2024
  4. Registered EUDAMED 454741010100000000001323J
  5. Listed FDA GUDID 04547410489873

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
FDR nano EUDAMED
Fdr Aqro GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
04547410489873 EUDAMED
DR-XD 1000 MBL WIN10 MDR US E GUDID
Primary DI / UDI-DI
04547410489873
Basic UDI-DI
454741010100000000001323J
510(k) Number
FDA product code
IZL
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1720
System or procedure pack
System which is a device in itself
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
04547410489873
GUDID
DR-XD 1000 MBL WIN10 MDR US E
Device classEUDAMED
Class IIb
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)