AmCAD-UT Detection 2.2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180006 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 AmCAD-UT Detection 2.2 is a computer-aided detection (CADe) software device classified under the product code LLZ. It functions as a Windows-based application designed to assist radiologists in analyzing thyroid ultrasound images by identifying and highlighting regions of interest, such as nodules, within user-defined or algorithm-suggested areas. This tool enhances diagnostic accuracy by providing automated detection cues while maintaining physician oversight. The device operates in conjunction with FDA-cleared ultrasound systems to streamline nodule assessment in thyroid imaging.
The AmCAD-UT Detection 2.2 is supplied as a software application for installation on compatible Windows systems, requiring no physical sterilization or single-use considerations. It is intended for use in radiology settings where thyroid ultrasound imaging is performed, adhering to regulatory standards outlined by its FDA 510(k) clearance (K180006) and MDR compliance. The device is non-invasive and does not interact directly with patients, relying solely on digital image analysis. Storage and usage require adherence to standard IT security protocols for medical imaging software, though no specific sterility or MRI safety constraints apply.
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: AmCAD-UT Detection 2.2 by AmCad BioMed Corporation | FDA 510(k) Summary, PDF AmCAD BioMed Corporation - Food and Drug Administration, PDF AmCad BioMed Corporation Nathan Liu Product Specialist FL.5-2, NO.167 ...
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 | K180006 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amcad Biomed Corporation
Sources (2)
- FDA 510(k) K180006 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026