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VEA Align - spineEOS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240582

by Eos Imaging

Identifiers

510(k) Number
K240582 FDA 510(k)
FDA Product Code
QIH FDA 510(k)
Models / Variants
VEA Align FDA 510(k)EUDAMED
spineEOS FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What clinical setting or specialty is VEA Align; spineEOS primarily designed for, and how does it assist healthcare professionals in their workflow?

VEA Align; spineEOS is designed for radiology settings and is intended to assist orthopedic surgeons, spine specialists, and radiologists. It automates the analysis of spinal radiographs by processing 2D X-ray images to evaluate spinal alignment and anatomical structures. This AI-based tool helps clinicians quickly assess spinal and lower limb alignment, streamlining the diagnostic process and reducing manual review time.

Is VEA Align; spineEOS a physical device or a software solution, and what does this mean for its use and maintenance?

VEA Align; spineEOS is a cloud-based software solution, not a physical device. This means it operates digitally without requiring physical components like disposables or hardware maintenance. Since it’s software, there are no sterility concerns or single-use limitations—it can be reused indefinitely as long as the system remains functional and connected to the cloud infrastructure.

How is VEA Align; spineEOS regulated, and what does this imply for its adoption in clinical practice?

VEA Align; spineEOS holds both FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for radiology AI tools. This implies it has undergone evaluation for safety and effectiveness in its intended use—automated spinal alignment analysis from X-ray images—allowing clinicians to integrate it with confidence in radiology workflows.

Does VEA Align; spineEOS require any special storage conditions, and how is it typically deployed in a clinical environment?

Since VEA Align; spineEOS is a cloud-based software solution, it doesn’t require physical storage like traditional medical devices. It is deployed in radiology departments via internet connectivity, allowing healthcare facilities to access it remotely. No refrigeration, humidity controls, or dedicated hardware storage is needed—only a stable network connection and compatible IT infrastructure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VEA Align - Physician AI Tools, EOS imaging: VEA Align; spineEOS (FDA-cleared AI medical device), VEA Align; spineEOS | EOS imaging radiology AI profile, VEA Align; spineEOS | FDA Radiology AI Device

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eos Imaging

Sources (2)

  • FDA 510(k) K240582 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026