NemoScan

Software Nemotec S.L. • Radiology • 12/11/2019

510(k)IEC 62304 Class C

Device Purpose

NemoScan is a software application designed to enhance dental implantology by providing robust tools for diagnostic support and comprehensive treatment planning. It accomplishes this through advanced image segmentation capabilities and by facilitating the efficient transfer and analysis of medical imaging data, primarily from CT scanners, for precise clinical decision-making.

Summary

NemoScan is a software application developed to support dental professionals in the diagnostic and treatment planning phases of dental implantology. Its core purpose is to provide clinicians with tools to analyze patient-specific imaging data, thereby aiding in the formulation of effective strategies for dental implant procedures. The software is designed to integrate into the clinical workflow, offering a platform for detailed case assessment and planning. Functionally, NemoScan operates as an image segmentation system, allowing users to isolate and examine specific anatomical structures from medical scans. It also manages the transfer of imaging information from sources like CT scanners, making this data available for diagnostic interpretation and treatment simulation within the software. These capabilities enable comprehensive visualization and planning critical for successful dental implant outcomes.

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

NemoScanDental ImplantologyDiagnostic SoftwareTreatment Planning SoftwareImage SegmentationCT Scan DataImaging Data TransferDental SoftwareMedical ImagingClinical Decision Support

Device Metadata

Submission Number

K192571

Company

Software Nemotec S.L.

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Intervention

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. How does NemoScan's image segmentation algorithm handle variations in image quality from different CT scanners?; What specific tools or modules within NemoScan facilitate the treatment planning process for complex dental implant cases (e.g., full-arch restorations, cases requiring bone grafting)?; Can NemoScan integrate with other dental software systems, such as CAD/CAM for surgical guide design or patient management systems?; What validation studies have been performed to assess the accuracy of measurements and segmentations made using NemoScan?; How does NemoScan address the visualization and avoidance of critical anatomical structures (e.g., inferior alveolar nerve, maxillary sinus) during implant planning?

Risk Classification

ESL Analysis

IEC 62304 ClassC

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (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(platform)

✓ 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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