Skip to content

IMRT - Bodyphantom M9800000

by IBA Dosimetry GmbH

Ref BS40-000

IMRT - Bodyphantom M9800000 (BS40-000) is a device classified as Class I in the EU and Class II in the US made by IBA Dosimetry GmbH, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI ++EIBAIMRTPHANTOMP5), cleared under FDA 510(k) K031634 on 29 Aug 2003 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI EIBAM98000000), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031634

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EIBAIMRTPHANTOMP5 Basic UDI-DI EIBAM98000000UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEIBAM98000000 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031634 Date29 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EIBAIMRTPHANTOMP5 registered 16 Oct 2026 Active
  • FDA 510(k) K031634 decided 29 Aug 2003 Active
  • FDA GUDID UDI-DI EIBAM98000000 listed 9 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031634
  2. Listed FDA GUDID EIBAM98000000
  3. Registered EUDAMED ++EIBAIMRTPHANTOMP5

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  • Withdrawn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
Universal I'mRT Phantom EUDAMED
IMRT - Bodyphantom GUDID
Generic name
Accelerator system quality assurance device
Model / Ref / Catalog
BS40-000, M9800000
Primary DI / UDI-DI
EIBAM98000000
Basic UDI-DI
++EIBAIMRTPHANTOMP5
Direct marketing DI
EIBAM98000000
510(k) Number
FDA product code
IYE
EMDN code
Z119002 Dosimeters
GMDN term
Accelerator system quality assurance device
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BS40-000
GUDID
M9800000
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: Accelerator system quality assurance device

Cleared under the same submission (K031634)

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from IBA Dosimetry GmbH

See all devices from IBA Dosimetry GmbH →

Properties

  • Serial number
Other properties (24, all answered No)