SterEOS Workstation
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Eos Imaging
Identifiers
- 510(k) Number
- K141137 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 SterEOS Workstation is a medical imaging device classified as a radiation processing device (product code LLZ) for interactive 3D reconstruction and measurement of 2D X-ray images. It enables orthopedic and radiology professionals to analyze spinal deformities, scoliosis, and musculoskeletal conditions in pediatric patients aged seven and older, as well as adult patients, through advanced digital processing tools.
This workstation is designed for use in radiology and orthopedic settings, where it accepts, transfers, displays, stores, and processes 2D X-ray images obtained from EOS imaging systems. It is supplied as a reusable device and is not intended for single-use applications. The SterEOS Workstation holds FDA 510(k) clearance (K141137) under the Traditional 510(k) review pathway and complies with MDR requirements. No specific MRI safety classification or sterility standards are noted in the available data.
Frequently asked questions
What types of patients can the SterEOS Workstation analyze, and what conditions does it focus on?
The SterEOS Workstation is designed for analyzing spinal deformities, scoliosis, and musculoskeletal conditions in pediatric patients aged seven and older, as well as adult patients. It uses interactive 3D reconstruction and measurement tools to process 2D X-ray images, helping orthopedic and radiology professionals assess these conditions in clinical settings.
Is the SterEOS Workstation intended for single-use, or can it be reused in a clinical setting?
The SterEOS Workstation is explicitly supplied as a reusable device and is not intended for single-use applications. This means it is built to withstand repeated use in radiology or orthopedic settings while processing and analyzing X-ray images from EOS imaging systems.
What regulatory pathways has the SterEOS Workstation undergone, and what does this mean for its use?
The SterEOS Workstation holds FDA 510(k) clearance under the Traditional 510(k) review pathway (K141137) and complies with MDR (Medical Device Regulation) requirements. This means it has been evaluated for safety and effectiveness by regulatory authorities and is authorized for use in clinical settings where 3D reconstruction and measurement of X-ray images are required.
What kind of imaging data does the SterEOS Workstation accept and process?
The SterEOS Workstation is designed to accept, transfer, display, store, and process 2D X-ray images specifically obtained from EOS imaging systems. It does not process other types of imaging data, such as MRI or CT scans, and relies on these X-ray inputs to generate 3D reconstructions for analysis.
Where can the SterEOS Workstation be used, and what clinical environments is it intended for?
The SterEOS Workstation is intended for use in radiology and orthopedic settings. It is specifically designed to support professionals in these fields by enabling detailed analysis of spinal and musculoskeletal conditions through advanced digital processing of X-ray images.
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: For Professionals - EOS imaging, EOS sterEOS Workstation - myHealthbox, EOSedge | Low dose 2D/3D radiation imaging platform
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141137 | Class II | Active |
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Manufacturer
- Manufacturer
- Eos Imaging
Sources (2)
- FDA 510(k) K141137 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026