VEA Align; spineEOS
FDA 510(k) K251747 · Eos Imaging
510(k) numberK251747
Submission
- Device name
- VEA Align; spineEOS
- Applicant
- Eos Imaging
Paris, FR - Received
- June 6, 2025
- Decision date
- August 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251078 | AutoDensityQIH · Traditional | 11/14/2025SE |
| K233920 | EOSedgeKPR · Traditional | 08/06/2024SE |
| K240582 | VEA Align; spineEOSQIH · Traditional | 06/25/2024SE |
| K231917 | VEA AlignQIH · Traditional | 01/05/2024SE |
| K232086 | spineEOSLLZ · Traditional | 10/24/2023SE |
| K202394 | EOSedgeKPR · Special | 09/16/2020SE |
| K192079 | EOSedgeKPR · Traditional | 11/27/2019SE |
| K172346 | sterEOS WorkstationLLZ · Traditional | 06/19/2018SE |
| K160914 | sterEOS WorkstationLLZ · Special | 04/22/2016SE |
| K152788 | EOS SystemKPR · Special | 10/21/2015SE |
Questions and answers
When was VEA Align; spineEOS cleared by the FDA?
VEA Align; spineEOS (K251747) received a 510(k) decision of Substantially Equivalent on August 15, 2025, 70 days after the submission was received.
What is the product code of K251747?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.