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Lung Vision System

Body Vision Medical Ltd. • Radiology • 04/18/2019

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The submitted text serves as a technical instruction for optimally viewing a PDF portfolio with specified Adobe software, rather than containing information about a medical device. Therefore, no analysis of a device's purpose, methodology, or scientific characteristics can be performed based on this content.

Summary

The provided document content does not describe a medical device, its purpose, methodology, science, or results. Instead, the text is a brief instructional message advising the user to open a PDF portfolio using specific software versions, namely Acrobat X or Adobe Reader X, or later, for the 'best experience,' and includes a suggestion to 'Get Adobe Reader Now!'. This indicates the provided text is likely a wrapper or instruction page rather than the substantive content intended for analysis. Consequently, a summary detailing any aspects of a medical device cannot be generated from this input, as no such information is present in the text supplied. The document's sole focus is on the technical requirements for accessing other potential content, not on providing that content itself.

AI Regulatory Concerns

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

Keywords

PDFAcrobat XAdobe Reader XPDF portfoliosoftware recommendationdocument viewinguser experienceplaceholder textcontent accesstechnical instruction

Device Metadata

Submission Number
K183593
Company
Body Vision Medical Ltd.
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Intervention
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. What specific information is expected to be found within the PDF portfolio mentioned in the text?; Are there alternative methods to access the content if Acrobat X or Adobe Reader X are unavailable, as suggested?; Given this text is a software recommendation, where is the actual document content intended for substantive analysis located?; How does the instruction 'For the best experience' relate to the fidelity or completeness of information within the PDF, if at all?; What are the implications for accessing the core information if a user cannot 'Get Adobe Reader Now!' as suggested by the text?

Risk Classification

ESL Analysis
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

Powered by SBOMator™

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 Score25/100
SBOM Evidence✓ Detected 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(software version)
✓ 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.

• Evidence of SBOM 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: ML-BOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Lung Vision System - Body Vision Medical Ltd. | ESL FDA AI Device Intelligence