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Head Adjuster

by Vision RT Ltd.

Ref 05056190500047

Head Adjuster (05056190500047) is a device classified as Class I in the EU and Class II in the US made by Vision RT Ltd., registered in EUDAMED on 18 Sep 2024 (Basic UDI-DI 5056190501006UD), cleared under FDA 510(k) K203387 on 4 Mar 2021 and listed in FDA GUDID since 23 Sep 2021 (UDI-DI 05056190500047), 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) K203387

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 Number5056190501006UD Basic UDI-DI 05056190500047UDI-DIDate18 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05056190500047 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK203387 Date4 Mar 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5056190501006UD registered 18 Sep 2024 Active
  • FDA 510(k) K203387 decided 4 Mar 2021 Active
  • FDA GUDID UDI-DI 05056190500047 listed 23 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203387
  2. Listed FDA GUDID 05056190500047
  3. Registered EUDAMED 5056190501006UD

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  • Withdrawn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
Head Adjuster EUDAMED
AlignRT Plus GUDID
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
05056190500047 EUDAMED
Head Adjuster GUDID
Primary DI / UDI-DI
05056190500047
Basic UDI-DI
5056190501006UD
Direct marketing DI
05056190500047
510(k) Number
FDA product code
IYE
EMDN code
Z11019080 Various radiotherapy and radiosurgery instruments - hardware accessories
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
05056190500047
GUDID
Head Adjuster
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
GB-MF-000010499
Authorised representative
Oticon A/S DK-AR-000006135

Related devices

Category: Multi-modality therapeutic radiation phantom, test object

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Vision RT Ltd.

See all devices from Vision RT Ltd. →

Properties

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