QUANTRA

HOLOGIC, INC. • Radiology • 09/12/2008

510(k)IEC 62304 Class B

Device Purpose

QuantraTM is a software application designed to analyze full-field digital mammography images to calculate volumetric breast density by estimating the ratio of fibroglandular tissue to total breast volume. This system provides quantitative, adjunctive information to radiologists, aiding in the assessment of breast tissue composition without offering diagnostic interpretation.

Summary

QuantraTM is a software application designed to work with Hologic digital mammography systems to estimate breast tissue volumes. Its primary function is to calculate volumetric breast density by determining the ratio of fibroglandular tissue to total breast volume from full-field digital mammography (FFDM) images. This software processes these images and provides numerical values for each breast, running on the Hologic Cenova DICOM server. The information generated by Quantra is intended as adjunctive data to aid radiologists in their assessment of breast tissue composition, and it is explicitly stated that it is not an interpretive or diagnostic tool.\n\nThe underlying science of Quantra involves image processing algorithms applied to digital mammograms to quantify different tissue types within the breast. The device operates without any direct patient contact and does not control life-sustaining equipment. Its development and manufacturing adhere to several quality and safety standards, including ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), NEMA DICOM PS 3 for image communication, and ANSI/AAMI SW68:2001 for software life cycle processes. Risk management includes a hazard analysis, with potential hazards classified as 'Minor,' controlled through software development, verification, and validation testing.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

QuantraVolumetric breast densityMammographyImage processingFibroglandular tissueSoftware applicationHologicDICOMBreast tissue compositionAdjunctive information

Device Metadata

Submission Number

K082483

Company

HOLOGIC, INC.

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. What specific algorithms does Quantra use to differentiate and quantify fibroglandular tissue versus total breast volume from FFDM images?; How does the accuracy of Quantra's volumetric breast density estimations compare across different breast densities and patient demographics?; What is the typical processing time for Quantra to analyze a set of mammography images and provide the density values?; Are there known limitations or image characteristics (e.g., artifacts, implant presence) that might affect the reliability of Quantra's breast density calculations?; How does the integration of Quantra with Hologic Cenova DICOM servers impact workflow efficiency in a clinical radiology setting?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score10/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment⚠ Not mentioned in summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials(server)

✓ Detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, SaaSBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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