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iGUIDE P10603-111-224

by 3C-Medical Intelligence GmbH

Ref P10603-111

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number04056719BUDI0000000005J4 Basic UDI-DI 04056719002268UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056719002268 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-3017-2017 FDA Class II initiated 19 Jun 2017

    Incorrect PEC values.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
iGUIDE Software 2.2.4 EUDAMED
iGUIDE GUDID
Generic Name
Accelerator system table, powered
Device Name
HexaPOD evo RT System
Model / Ref / Catalog
P10603-111, P10603-111-224
Description
iGUIDE is the control software of the HexaPOD™ evo RT Couchtop. Software Revision 2.2.4
Primary DI / UDI-DI
04056719002268
Basic UDI-DI
04056719BUDI0000000005J4
Direct Marketing DI
04056719002268
510(k) Number
FDA Product Code
IYE
EMDN Code
Z11010199 Linear accelerators – other
GMDN Term
Accelerator system table, powered
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
P10603-111
GUDID
P10603-111-224
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K143485)

Other devices from 3C-Medical Intelligence GmbH

See all devices from 3C-Medical Intelligence GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No