Genius AI Detection 2.0 with CC-MLO Correlation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230096 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 Genius AI Detection 2.0 with CC-MLO Correlation is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to analyze digital breast imaging data. It employs artificial intelligence to identify and correlate suspicious soft tissue densities and calcifications across craniocaudal (CC) and mediolateral oblique (MLO) views. The software generates confidence scores to assist radiologists in interpreting breast cancer screening results, enhancing lesion detection accuracy. Its functionality extends to tomosynthesis slices, 3DQuorum SmartSlices, and synthesized 2D images, providing multi-view correlation for comprehensive assessment.
This software is intended for use in radiology settings, functioning as a standalone tool integrated with imaging systems such as SecurView 12.0. It is not a single-use or reusable device but rather a software application installed on a compatible system. The device operates in a non-sterile environment and does not require sterilization. No specific MRI safety classification is provided, but its use is restricted to radiology workflows where digital imaging is processed. The software is authorized under FDA 510K clearance (K230096) and falls under Device Class II (QDQ product code).
Genius AI Detection 2.0 with CC-MLO Correlation
Frequently asked questions
What is the Genius AI Detection 2.0 with CC-MLO Correlation used for?
This software is designed to assist radiologists in breast cancer screening by analyzing digital breast imaging data. It uses artificial intelligence to identify and correlate suspicious soft tissue densities and calcifications across craniocaudal (CC) and mediolateral oblique (MLO) views, including tomosynthesis slices and synthesized 2D images. The tool generates confidence scores to help improve lesion detection accuracy during interpretation of breast cancer screening results.
How is the Genius AI Detection 2.0 with CC-MLO Correlation supplied and installed?
The Genius AI Detection 2.0 with CC-MLO Correlation is a software application, not a physical device. It is installed on compatible imaging systems, such as SecurView 12.0, within radiology settings. The software operates as a standalone tool integrated into these systems and does not require physical sterilization or disposal.
Is the Genius AI Detection 2.0 with CC-MLO Correlation single-use or reusable?
This software is not a single-use or reusable device in the traditional sense. It is a permanent installation on compatible imaging systems and remains functional as long as the system and software are maintained. There is no need for sterilization or replacement after use, as it operates in a non-sterile environment.
What imaging modalities does the Genius AI Detection 2.0 with CC-MLO Correlation support?
The software supports analysis of digital breast imaging data, including craniocaudal (CC) and mediolateral oblique (MLO) views. Additionally, it extends its functionality to tomosynthesis slices, 3DQuorum SmartSlices, and synthesized 2D images, enabling multi-view correlation for a comprehensive assessment of suspicious lesions.
What regulatory pathway was followed for the Genius AI Detection 2.0 with CC-MLO Correlation?
The software was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process. It was determined to be substantially equivalent to a predicate device and falls under Device Class II, categorized under the QDQ product code (Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer).
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: Genius AI® Detection | Mammography AI Software | Hologic, Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc ..., Genius AI Detection 2.0 with CC-MLO Correlation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230096 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K230096 24 fields · synced Oct 1, 2026