KEOPS Balance Analyzer 3D
FDA 510(k)Class II (US FDA 510(k))
by S.m.a.i.o
Identifiers
- 510(k) Number
- K213975 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
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)
The KEOPS Balance Analyzer 3D is a device intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. It allows surgeons and service providers to perform spine-related measurements on images and plan surgical procedures.
The device is supplied by S.M.A.I.O and has received FDA 510(k) clearance with the product code LLZ. It is intended for use in radiology settings and includes tools for surgical planning. The device is not described as single-use or reusable, and no information regarding sterility or MRI safety is provided.
Frequently asked questions
What is the KEOPS Balance Analyzer 3D used for?
The KEOPS Balance Analyzer 3D is a device designed to assist healthcare professionals in viewing and measuring images as well as planning spine surgeries. It provides surgeons and service providers with specialized tools for performing spine-related measurements on medical images and planning surgical procedures.
How is the KEOPS Balance Analyzer 3D supplied?
The device is supplied by S.M.A.I.O, a manufacturer based in Saint-Priest, France. The company provides the KEOPS Balance Analyzer 3D as a medical device for use in radiology settings, though specific details about packaging or supply quantities are not provided in the available information.
What is the regulatory status of the KEOPS Balance Analyzer 3D?
The KEOPS Balance Analyzer 3D has received FDA 510(k) clearance with the product code LLZ. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway, with the review handled by the Radiology Advisory Committee. The clearance was granted on May 6, 2022, with K number K213975.
Is the KEOPS Balance Analyzer 3D single-use or reusable?
The available information does not specify whether the KEOPS Balance Analyzer 3D is designed for single-use or multiple uses. Similarly, no details regarding sterility requirements or MRI safety are provided in the device description or specifications.
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: PDF Keops Balance Analyzer 3d Ce Instructions for Use - Smaio, PDF KEOPS BALANCE ANALYZER 3D INSTRUCTIONS FOR USE Year of 1, PDF 3. Statement of intended use - smaio.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213975 | Class II | Active |
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Manufacturer
- Manufacturer
- S.m.a.i.o
Sources (1)
- FDA 510(k) K213975 24 fields · synced Sep 23, 2026