spineEOS
FDA 510(k) K232086 · Eos Imaging
510(k) numberK232086
Submission
- Device name
- spineEOS
- Applicant
- Eos Imaging
Paris, FR - Received
- July 13, 2023
- Decision date
- October 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
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| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K251078 | AutoDensityQIH · Traditional | 11/14/2025SE |
| K251747 | VEA Align; spineEOSQIH · Traditional | 08/15/2025SE |
| K233920 | EOSedgeKPR · Traditional | 08/06/2024SE |
| K240582 | VEA Align; spineEOSQIH · Traditional | 06/25/2024SE |
| K231917 | VEA AlignQIH · Traditional | 01/05/2024SE |
| 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 spineEOS cleared by the FDA?
spineEOS (K232086) received a 510(k) decision of Substantially Equivalent on October 24, 2023, 103 days after the submission was received.
What is the product code of K232086?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.