Skip to content

VEA Align; spineEOS

by Eos Imaging 2 variants

510(k) K240582

Active European Union and United States

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240582↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240582 Date25 Jun 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240582 decided 25 Jun 2024 Active
  • EUDAMED Active

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  • Withdrawn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 · 510(k)

510(k) Number
FDA product code
QIH
Models / Variants
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

VEA Align; spineEOS is an AI-based medical imaging software designed for automated analysis of spinal radiographs. It falls under the category of radiology AI tools, specifically for processing X-ray images to evaluate spinal alignment and anatomical structures.

This cloud-based software is intended for use in radiology settings, where it assists healthcare professionals in assessing spinal and lower limb alignment from 2D X-ray images. The device is supplied as a software solution with FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for radiology AI devices. No sterility or single-use requirements apply, as it operates digitally without physical components.

Devices cleared under K240582

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K240582
UDI-DISize and differences
spineEOS 4.1
EOS IMAGING
4.103663999000313
Prescription: yes
No longer on the market
spineEOS 5.x
EOS IMAGING
5.x03663999000375
Prescription: no
No longer on the market
VEA Align 2.1
EOS IMAGING
2.103663999000337
Prescription: yes
No longer on the market
VEA Align 3.x
EOS IMAGING
3.x03663999000412
Prescription: no
On the market

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing 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 →