PowerLook Tomo Detection V2 Software
FDA 510(k)Class II (US FDA 510(k))
by Icad, Inc.
Identifiers
- 510(k) Number
- K182373 FDA 510(k)
- FDA Product Code
- QDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PowerLook Tomo Detection V2 Software is a Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. It is designed to process 3D digital breast tomosynthesis slices to detect soft tissue densities and calcifications. The software uses deep learning to identify suspicious lesions and assigns a score to each detection. It is intended to assist physicians in identifying lesions and calcifications in digital breast tomosynthesis images.
The PowerLook Tomo Detection V2 Software is supplied as a software device and is regulated under the product code QDQ. It has been cleared by the FDA under the traditional clearance type with the decision code SESE. The software is classified as a class 2 device and is registered under multiple FEI numbers. It is used in the medical specialty of Radiology and is subject to the regulation number 892.2090.
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: K182373 FDA 510(k) - PowerLook Tomo Detection V2 Software, PowerLook Tomo Detection V2 Software - physicianaitools.com, PowerLook Tomo Detection V2 Software (K182373) - Innolitics, FDA K182373 PowerLook® Tomo Detection V2 Software
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182373 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA 510(k) K182373 24 fields · synced Sep 25, 2026