VEA Align
VEA Align assists global skeletal alignment assessment using frontal and lateral X-rays from EOS or EOSedge systems. A machine-learning algorithm proposes anatomical landmarks, which the…
VEA Align assists global skeletal alignment assessment using frontal and lateral X-rays from EOS or EOSedge systems. A machine-learning algorithm proposes anatomical landmarks, which the user adjusts and validates.
The software calculates angles, lengths and alignment parameters from those landmarks and recalculates the values when their positions change. It supports assessment of spinal deformity, degenerative disease and lower-limb alignment disorders.
Images and Patients
Use is for adults and children aged seven years and older. The cloud-hosted application relies on VEA Portal for image transfer and access control. Clinical judgment is required to interpret its patient-specific measurements and any comparison with published normative values.
Who Else Makes It
Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
| Wuhan United Imaging Healthcare Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
| Keya Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | EOS imaging, France |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K231917 |
| Record published | 2024-05-29 |
| Record revised | 2025-03-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.x | In distribution | |
| 4.x | In distribution | |
| 1.0 | Withdrawn | |
| 2.1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imbio RV/LV | Imbio, LLC | 5 |
| Qlab Advanced Quantification Software | Philips Ultrasound LLC | 3 |
| uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 3 |
| Scenium | Siemens Medical Solutions USA, Inc. | 3 |
| syngo.MI General | Siemens Medical Solutions USA, Inc. | 3 |
| Neosoma Dashboard | Neosoma, Inc. | 3 |
| BriefCase-Quantification | Aidoc Medical Ltd. | 3 |
| OrthoNext™ Platform System Software | Orthofix SRL | 3 |
| MI View&GO | Siemens Medical Solutions USA, Inc. | 3 |
| FEops | Feops NV | 3 |
| AI-Rad Companion Brain MR | Siemens Healthcare Limited | 3 |
| Tomtec-Arena | Tomtec Imaging Systems GMBH | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251078 | 2025-11-14 |
| K251747 | 2025-08-15 |
| K240582 | 2024-06-25 |
| K231917 | 2024-01-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.