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Intelli-C Accessory 03284900

by Nrt - Nordisk Røntgen Teknik A/S

Part of a family of 17 devices: see the family page

Ref 03284900Model CFP Accessories

Intelli-C Accessory 03284900 is a device classified as Class I in the EU and Class II in the US made by Nrt - Nordisk Røntgen Teknik A/S, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 571346413200AG), cleared under FDA 510(k) K173631 on 11 Jul 2018 and listed in FDA GUDID since 31 May 2022 (UDI-DI 05713464000756), active as of 22 Oct 2026. 4 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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173631

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number571346413200AG Basic UDI-DI 05713464000756UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713464000756 UDI-DI Date31 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173631 Date11 Jul 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 571346413200AG registered 21 May 2026 Active
  • FDA 510(k) K173631 decided 11 Jul 2018 Active
  • FDA GUDID UDI-DI 05713464000756 listed 31 May 2022 Listed

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1784-2024 FDA Class II initiated 17 Apr 2024

    X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

  • 2 recalls, same reason

    • Ongoing Z-1669-2023 FDA Class II initiated 27 Apr 2023
    • Ongoing Z-1668-2023 FDA Class II initiated 27 Apr 2023

    There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.

    • Ongoing Z-0526-2022 FDA Class II initiated 21 Jan 2022

    Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.

Timeline

7 dated events

  1. Cleared FDA 510(k) K173631
  2. Recall initiated FDA recalls Z-0526-2022
  3. Listed FDA GUDID 05713464000756
  4. Recall initiated FDA recalls Z-1669-2023
  5. Recall initiated FDA recalls Z-1668-2023
  6. Recall initiated FDA recalls Z-1784-2024
  7. Registered EUDAMED 571346413200AG

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
Pair of Hand Grips EUDAMED
Intelli-C Accessory GUDID
Generic name
Radiological arm/leg positioner
Model / reference
03284900, CFP Accessories
Primary DI / UDI-DI
05713464000756
Basic UDI-DI
571346413200AG
Direct marketing DI
05713464000756
510(k) Number
FDA product code
JAA, OWB
EMDN code
Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
GMDN term
Radiological arm/leg positioner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Radiological arm/leg positioner

Cleared under the same submission (K173631)

and 8 more cleared under K173631

Similar devices in this category

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

Other devices from Nrt - Nordisk Røntgen Teknik A/S

See all devices from Nrt - Nordisk Røntgen Teknik A/S →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)