Densityai
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Densitas Inc
Identifiers
- 510(k) Number
- K192973 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)
Densityai is an AI-powered software tool designed for automated breast density assessment from mammographic images. Classified as a radiological imaging software (Product Code LLZ), it employs deep-learning algorithms to standardize and quantify breast density measurements, reducing variability inherent in visual radiologist interpretation. The device supports clinical decision-making by providing objective, reproducible density classifications aligned with established nomenclature standards. Its output aids in risk stratification and workflow optimization for breast cancer screening programs.
Densityai is supplied as a software application integrated into mammography systems, requiring no additional hardware. It operates in radiology departments and screening centers, processing digital mammograms to generate standardized density scores. The software is intended for single-use per image analysis, with no sterility or reprocessing requirements. Compliance with FDA 510(k) clearance (K192973) and EU MDR ensures its regulatory standing for use in diagnostic imaging workflows. No MRI safety considerations apply, as it is a non-invasive software solution.
Frequently asked questions
How does densityai integrate into existing mammography workflows and what hardware requirements does it have?
Densityai integrates directly into mammography systems as a software application, requiring no additional hardware beyond the existing digital mammography equipment. Since it processes digital mammograms, it works seamlessly within radiology departments and screening centers that already use digital imaging systems. The software analyzes images on-site to provide standardized breast density scores, streamlining workflows without disrupting current infrastructure.
Is densityai reusable or designed for single-use, and what does that mean for my facility’s workflow?
Densityai is designed for single-use per image analysis, meaning each mammogram is processed independently by the software. This eliminates the need for sterilization or reprocessing, as the software itself is not a physical device that requires cleaning or reuse. Clinicians can rely on consistent, objective density assessments without additional logistical steps, improving efficiency in screening programs.
What regulatory approvals does densityai hold, and how does that affect its use in clinical settings?
Densityai holds FDA 510(k) clearance (K192973) and complies with EU MDR, confirming its regulatory standing for use in diagnostic imaging workflows. The FDA clearance under Product Code LLZ (radiological imaging software) and the MDR compliance ensure it meets stringent standards for automated breast density assessment. Clinicians can trust its reliability for standardized, reproducible density classifications in breast cancer screening programs.
Does densityai require any special storage conditions, and how is it typically deployed in a radiology department?
Since densityai is a software application, it does not require physical storage like traditional medical devices. It is deployed as part of the mammography system’s software infrastructure, accessible via authorized workstations in radiology departments or screening centers. No refrigeration, humidity controls, or other environmental conditions are needed—only a stable digital imaging system and network access to run the AI-powered analysis.
How does densityai’s AI-driven approach differ from traditional radiologist interpretations of breast density?
Densityai uses deep-learning algorithms to automate and standardize breast density assessment from mammographic images, reducing the variability often seen in visual radiologist interpretations. By quantifying density objectively and aligning with established nomenclature standards, it provides reproducible classifications that support consistent risk stratification. This aids clinicians in clinical decision-making and optimizes workflows in breast cancer screening programs.
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: Product Information | densitas® densityAI™, Densityai - Densitas, densitas densityai - Physician Ai Tools, Densitas: Products, FDA Status & Funding | Physician AI Tools
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 | K192973 | Class II | Active |
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Manufacturer
- Manufacturer
- Densitas Inc
- FDA Applicant
- Densitas, Inc.
Sources (2)
- FDA 510(k) K192973 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026