ALI 3D Tool Module for Medical Images
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003762 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 ALI 3D Tool Module for Medical Images is a software module designed for advanced image processing in radiology. It supports complex functions such as image segmentation, multimodality image registration, and 3D visualization to aid in the interpretation and analysis of medical imaging data. This tool enhances diagnostic capabilities by enabling precise manipulation and quantification of medical images, improving clinical decision-making. Its classification as a Class II X-ray system aligns with regulatory standards for medical imaging software.
This module is intended for integration into radiology workflows, providing specialized tools for radiologists and imaging technicians. Supplied as part of a software system, it operates within a PACS (Picture Archiving and Communication System) environment to process and analyze medical images. The device holds FDA 510(k) clearance (K003762) under the Traditional pathway, reflecting its compliance with U.S. regulatory requirements for medical imaging software. No third-party review was involved in its clearance process, and the product code assigned is LLZ.
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: ALI 3D TOOL MODULE FOR MEDICAL IMAGES - Innolitics, Ali 3D Tool Module For Medical Images - allmed.wiki, ALI 3D TOOL MODULE FOR MEDICAL IMAGES 510(k) K003762 - FDA.report, ALI UltraPACS GX workstation - Axis Imaging News
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003762 | Class II | Active |
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Manufacturer
- Manufacturer
- A.L.I. Technologies, Inc.
Sources (1)
- FDA 510(k) K003762 24 fields · synced Oct 6, 2026