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Rt-4546-03

by Qfix

Ref RT-4546-03Model Breast and Pelvis

Rt-4546-03 is a device classified as Class I in the EU and Class II in the US made by Qfix, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621BREASTPELVISTG), cleared under FDA 510(k) K060671 on 4 May 2006 and listed in FDA GUDID since 2 Dec 2025 (UDI-DI 00841962120401), active as of 22 Oct 2026.

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060671

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 Number8419621BREASTPELVISTG Basic UDI-DI 00841962120401UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841962120401 UDI-DI Date2 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060671 Date4 May 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8419621BREASTPELVISTG registered 22 May 2026 Active
  • FDA 510(k) K060671 decided 4 May 2006 Active
  • FDA GUDID UDI-DI 00841962120401 listed 2 Dec 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060671
  2. Listed FDA GUDID 00841962120401
  3. Registered EUDAMED 8419621BREASTPELVISTG

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  • Withdrawn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
Portrait Head Only Mask Adapter for Access Supine
Generic name
Radiological breast positioner, non-wearable
Model / Ref / Catalog
Breast and Pelvis, RT-4546-03
Primary DI / UDI-DI
00841962120401
Basic UDI-DI
8419621BREASTPELVISTG
510(k) Number
FDA product code
JAI
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Radiological breast positioner, non-wearable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5770
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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.

Manufacturer details

EUDAMED SRN
US-MF-000002762
Authorised representative
Advena SRL IT-AR-000051131

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

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