Clever One

Ewoosoft Co., Ltd • Radiology • 05/23/2025

510(k)IEC 62304 Class B

Device Purpose

Clever One is a dental imaging software designed to support diagnosis and treatment by providing advanced 2D and 3D visualization and analysis of DICOM-compliant medical images. Its functionality, validated as substantially equivalent to existing systems, includes image acquisition, processing, editing, and critical preoperative planning tools like implant simulation and bone density analysis for trained medical professionals.

Summary

Ewoosoft Co., Ltd.'s dental imaging software, Clever One, has received a determination of substantial equivalence to existing legally marketed devices, allowing its introduction to the market as a Medical Image Management and Processing System. This software is specifically intended for use by trained medical professionals to aid in diagnosis and treatment, providing essential tools for viewing and interpreting DICOM-compliant medical images. Clever One's scientific methodology involves interfacing with various dental imaging equipment, including CT, panoramic, cephalometric, and intraoral systems, to offer comprehensive 2D viewing and analysis, alongside advanced 3D visualization. Its core functionalities encompass image acquisition, processing, editing, and detailed analysis, extending to critical preoperative planning features such as implant simulation and bone density analysis, all validated through a thorough comparison to predicate devices ensuring alignment in technology, operational principles, and safety.

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

Clever OneDental imaging softwareMedical Image ManagementDICOM-compliant2D/3D visualizationImplant simulationBone density analysisPreoperative planningSubstantial equivalenceMedical professionals

Device Metadata

Submission Number

K250005

Company

Ewoosoft 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 specific clinical data or studies support the accuracy and reliability of Clever One's implant simulation and bone density analysis features for diverse patient populations?; How does Clever One integrate with and enhance the workflow of existing dental practice management systems beyond just imaging equipment interfaces?; Are there any reported limitations or specific scenarios where Clever One's 2D or 3D visualization capabilities might not be optimal compared to predicate devices?; What ongoing technical support and software update mechanisms are in place to ensure Clever One remains compatible with evolving imaging standards and operating systems?; Can the software be customized or adapted for specific dental specialties, and are there plans for future modules beyond its current scope?

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 Score20/100

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✓ Detected in Summary

§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(operational)

✓ 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 OBOM detected in AI-generated device summary.

• 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.

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

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