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Mobetron

by Intraop Medical, Inc.

Ref Mobetron

Mobetron is a device classified as Class IIb in the EU and Class II in the US made by Intraop Medical, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-00861396000308), cleared under FDA 510(k) K981112 on 24 Jul 1998 and listed in FDA GUDID since 15 Jun 2018 (UDI-DI 00861396000308), active as of 24 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K981112

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/MDD EUDAMED NumberB-00861396000308 Basic UDI-DI 00861396000308UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00861396000308 UDI-DI Date15 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK981112 Date24 Jul 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00861396000308 registered 28 May 2026 Active
  • FDA 510(k) K981112 decided 24 Jul 1998 Active
  • FDA GUDID UDI-DI 00861396000308 listed 15 Jun 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-0014-2009 FDA Unclassified (pre-2012) initiated 20 Jun 2008

    Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.

Timeline

4 dated events

  1. Cleared FDA 510(k) K981112
  2. Recall initiated FDA recalls Z-0014-2009
  3. Listed FDA GUDID 00861396000308
  4. Registered EUDAMED B-00861396000308

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Linear accelerator system
Device name
Electron Beam Radiation Therapy System
Model / reference
MOBETRON
Primary DI / UDI-DI
00861396000308
Basic UDI-DI
B-00861396000308
510(k) Number
FDA product code
LHN
EMDN code
Z11010104 Intra-operative linear accelerators
GMDN term
Linear accelerator system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Linear accelerator system

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS.

Other devices from Intraop Medical, Inc.

  • Mobetron

    Class II

Properties

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