Skip to content

AMX Navigate

by GE Medical Systems, L.L.C.

Ref 5844925

AMX Navigate (5844925) is a device classified as Class IIb in the EU and Class II in the US made by GE Medical Systems, L.L.C., registered in EUDAMED on 3 May 2023 (Basic UDI-DI 8406821BUG00267HN), cleared under FDA 510(k) K210982 on 28 Apr 2021 and listed in FDA GUDID since 22 Oct 2021 (UDI-DI 00195278003348), active as of 23 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210982

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00267HN Basic UDI-DI 00195278003348UDI-DIDate3 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278003348 UDI-DI Date22 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK210982 Date28 Apr 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00267HN registered 3 May 2023 Active
  • FDA 510(k) K210982 decided 28 Apr 2021 Active
  • FDA GUDID UDI-DI 00195278003348 listed 22 Oct 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-2590-2021 FDA Class II initiated 24 Jun 2021

    An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.

Timeline

4 dated events

  1. Cleared FDA 510(k) K210982
  2. Recall initiated FDA recalls Z-2590-2021
  3. Listed FDA GUDID 00195278003348
  4. Registered EUDAMED 8406821BUG00267HN

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  • Withdrawn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
AMX Navigate EUDAMED
Amx GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Model / Ref / Catalog
5844925, Navigate
Primary DI / UDI-DI
00195278003348
Basic UDI-DI
8406821BUG00267HN
510(k) Number
FDA product code
IZL, MQB
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1720, 892.1680
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5844925
GUDID
Navigate
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: Mobile basic diagnostic x-ray system, digital

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

Other devices from GE Medical Systems, L.L.C.

  • NA SIGNA Bolt

    Class II

  • 6265300-60

    Class II

  • 6265300-62

    Class II

  • Photonova Spectra

    Class II

See all devices from GE Medical Systems, L.L.C. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)