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AlignRT 8.1.x

by Vision RT Ltd.

Part of a family of 39 devices: see the family page

Ref AlignRT 8.1

AlignRT 8.1.x is a medical device (EU MDR Class IIb; FDA Class II; FDA product code IYE, Accelerator, Linear, Medical; EMDN category various radiotherapy and radiosurgery instruments) made by Vision RT Ltd., cleared under FDA 510(k) K253012 on 18 Mar 2026, registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI 5056190500573VE) and listed in FDA GUDID since 30 Jul 2026 (UDI-DI 05056190501211), 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) K253012

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056190501211 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253012 Date18 Mar 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number5056190500573VE Basic UDI-DI 05056190501211UDI-DIDate9 Mar 2026RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K253012 decided 18 Mar 2026 Active
  • EUDAMED Basic UDI-DI 5056190500573VE registered 9 Mar 2026 Active
  • FDA GUDID UDI-DI 05056190501211 listed 30 Jul 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 5056190500573VE
  2. Cleared FDA 510(k) K253012
  3. Listed FDA GUDID 05056190501211

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  • Withdrawn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
AlignRT 8.1.x EUDAMED
AlignRT Plus GUDID
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
AlignRT 8.1 EUDAMED
8.1 GUDID
Primary DI / UDI-DI
05056190501211
Basic UDI-DI
5056190500573VE
Direct marketing DI
05056190501211
510(k) Number
FDA product code
IYE
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AlignRT 8.1
GUDID
8.1
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
GB-MF-000010499
Authorised representative
Oticon A/S DK-AR-000006135

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

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)