Identity
- Trade Name
- LSN EUDAMED
- Device Name
- LSN EUDAMED
- Model / Reference
- LSN EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-B319LSN10JD EUDAMED
- Basic UDI-DI
- B-B319LSN10JD EUDAMED
- 510(k) Number
- K201092 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The LSN is a Medical Image Processing Device (FDA Product Code JAK) designed for the analysis and quantification of radiological images, specifically for brain tumor characterization. It processes imaging data to provide objective measurements and metrics that assist in diagnostic and treatment planning workflows.
This device is supplied as software and operates within a clinical radiology setting, requiring integration with existing imaging systems for data input. It is intended for single-use per imaging session, with no sterility requirements, and is classified as non-MRI conditional. Authorisations include FDA 510(k) clearance under the Medical Devices Directive (MDD) and are applicable in the United States. No third-party reprocessing is permitted.
Frequently asked questions
What clinical workflows does the LSN support, and how does it integrate with existing systems?
The LSN is designed to assist in brain tumor characterization by analyzing radiological images to provide objective measurements and metrics. It operates as a software tool that requires integration with existing imaging systems to process imaging data. This integration supports diagnostic and treatment planning workflows by offering quantitative insights derived from brain scans, helping clinicians refine their assessments without requiring additional hardware.
Is the LSN intended for repeated use across multiple patients, or is it single-use per session?
The LSN is specified for single-use per imaging session. Since it is a software-based device, it does not require physical reprocessing or sterilization between uses. Each session’s analysis is independent, ensuring data integrity and compliance with its intended workflow.
Does the LSN have any restrictions on use in environments with MRI equipment, and what are its regulatory approvals?
The LSN is explicitly labeled as non-MRI conditional, meaning it should not be used in direct proximity to MRI systems where electromagnetic interference could occur. Regulatory approvals include FDA 510(k) clearance under the Medical Devices Directive (MDD), making it legally authorized for use in the United States as described. No third-party reprocessing is permitted, aligning with its software-only design.
What types of brain imaging data can the LSN process, and does it require any specific hardware beyond standard radiology systems?
The LSN is tailored for the analysis of radiological images specifically related to brain tumors, though the exact imaging modalities aren’t detailed beyond this context. It functions as standalone software, meaning it relies on integration with existing radiology systems (such as PACS or DICOM-compatible platforms) to access and process imaging data. No additional hardware beyond the user’s standard radiology infrastructure is required.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201092 | Class II | Active |
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Manufacturer
- Manufacturer
- Imaging Biometrics, LLC
Sources (2)
- FDA 510(k) K201092 24 fields · synced Sep 18, 2026
- EUDAMED 7b1e065c-dea9-4e19-a225-3b74ace5967c 61 fields · synced Jul 25, 2026