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VEA Align

by EOS imaging

Ref VEA Align

VEA Align is a device classified as Class IIa in the EU and Class II in the US made by Eos Imaging, registered in EUDAMED on 19 Jun 2025 (Basic UDI-DI 3663999ALI01Y8), cleared under FDA 510(k) K240582 on 25 Jun 2024 (3 earlier submissions) and listed in FDA GUDID since 1 Aug 2025 (UDI-DI 03663999000412), 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240582

+3 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03663999000412 UDI-DI Date1 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3663999ALI01Y8 Basic UDI-DI 03663999000412UDI-DIDate19 Jun 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240582 Date25 Jun 2024DecidedStatusActive
United StatesFDA 510(k) 510(k) NumberK231917 Date5 Jan 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3663999ALI01Y8 registered 19 Jun 2025 Active
  • FDA 510(k) K240582 decided 25 Jun 2024 Active· +3 more in the status table
  • FDA GUDID UDI-DI 03663999000412 listed 1 Aug 2025 Listed

Recalls

1 recall · FDA

    • Terminated Z-1460-2015 FDA Class II initiated 17 Feb 2015 on shared 510(k) K123740

    When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Cleared FDA 510(k) K120721
  2. Cleared FDA 510(k) K123740
  3. Recall initiated FDA recalls Z-1460-2015
  4. Cleared FDA 510(k) K231917
  5. Cleared FDA 510(k) K240582
  6. Registered EUDAMED 3663999ALI01Y8
  7. Listed FDA GUDID 03663999000412

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Basic x-ray clinical assessment support software
Model / reference
VEA Align EUDAMED
3.x GUDID
Primary DI / UDI-DI
03663999000412
Basic UDI-DI
3663999ALI01Y8
Direct marketing DI
03663999000412
510(k) Number
FDA product code
QIH
EMDN code
Z11030592 Radiology instruments - medical device software
GMDN term
Basic x-ray clinical assessment support software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VEA Align
GUDID
3.x
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
FR-MF-000000502

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Eos Imaging

  • spineEOS 6.x

    Class II

  • AutoDensity 1.3

    Class II

  • VEA Align 4.x

    Class II

  • EOS System

    Class II

See all devices from Eos Imaging →

Properties

  • Measuring function
  • Lot / batch number
Other properties (23, all answered No)