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RT CouchTop XD

by Philips Medical Systems Nederland B.V.

Ref 989603083753

RT CouchTop XD (989603083753) is a device classified as Class I in the EU and Class II in the US made by Philips Medical Systems Nederland B.V., registered in EUDAMED on 6 May 2025 (Basic UDI-DI 0884838BM952TS), cleared under FDA 510(k) K214081 on 5 Apr 2022 and listed in FDA GUDID since 1 Sep 2022 (UDI-DI 00884838112780), 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) K214081

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 Number0884838BM952TS Basic UDI-DI 00884838112780UDI-DIDate6 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838112780 UDI-DI Date1 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK214081 Date5 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM952TS registered 6 May 2025 Active
  • FDA 510(k) K214081 decided 5 Apr 2022 Active
  • FDA GUDID UDI-DI 00884838112780 listed 1 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K214081
  2. Listed FDA GUDID 00884838112780
  3. Registered EUDAMED 0884838BM952TS

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  • Withdrawn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
RT CouchTop XD EUDAMED
MR-Rt GUDID
Generic name
Radiation therapy treatment planning positioning kit
Device name
Ingenia MR-RT hardware
Model / Ref / Catalog
989603083753, RT CouchTop XD
Primary DI / UDI-DI
00884838112780
Basic UDI-DI
0884838BM952TS
FDA product code
MUJ
EMDN code
Z1105018099 Magnetic resonance (MR) systems - hardware accessories - other
GMDN term
Radiation therapy treatment planning positioning kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
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
989603083753
GUDID
RT CouchTop XD
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
NL-MF-000001489

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)