AVIEW CAC

Coreline Soft Co., Ltd. • Radiology • 02/14/2025

510(k)IEC 62304 Class B

Device Purpose

The AVIEW CAC device is a medical image management and processing system designed for the quantitative analysis of coronary artery calcified plaques using non-contrast/non-gated Chest CT scans. Its primary purpose is to calculate Agatston scores for cardiovascular risk stratification, enabling healthcare professionals to assess adult patients' cardiac health based on existing CT studies.

Summary

Coreline Soft Co., Ltd. has received clearance for its AVIEW CAC device, a medical image management and processing system, confirming its substantial equivalence to previously marketed devices and compliance with regulatory standards. This system is specifically designed for the quantitative analysis of calcified plaques in the coronary arteries, utilizing non-contrast/non-gated Chest CT scans to achieve its purpose. The AVIEW CAC system is intended for use by healthcare professionals, including radiologists and cardiologists, enabling them to calculate the Agatston score, segment and evaluate coronary arteries, and provide risk stratification based on calcium score, gender, and age. The device also facilitates the storage, transfer, inquiry, and display of CT data both on-premises and via mobile devices, specifically for analyzing existing CT studies from adult patients over 40 years old, with validation for scans from General Electric (GE) equipment.

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

AVIEW CACCoronary Artery CalcificationAgatston scoreChest CTNon-contrast imagingMedical image managementRisk stratificationQuantitative analysisRegulatory clearanceHealthcare professionals

Device Metadata

Submission Number

K243696

Company

Coreline Soft Co., Ltd.

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What is the inter-reader and intra-reader variability of the AVIEW CAC system's Agatston score calculation in a clinical setting?; How does the AVIEW CAC system's performance compare when analyzing CT scans from scanner manufacturers other than GE, despite the stated validation?; What specific clinical trials or studies support the accuracy and reliability of the AVIEW CAC system's risk stratification capabilities?; Does the AVIEW CAC system provide volumetric calcium scoring in addition to the Agatston score, and if so, how does it integrate into the risk assessment?; What are the technical specifications and computational requirements for the AVIEW CAC system, particularly for its on-premises and mobile data handling?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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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 Score0/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan⚠ Not in summary - likely in full submission per §524B

§524B ApplicableYes

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

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not 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.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

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

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

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