510(k)Cardiology / Radiology
AI-Based Cardiac Imaging Device
?Before ESL
- • Unknown open-source components in the build
- • No SBOM produced for FDA submission
- • 340 unresolved static analysis findings (MISRA C:2023)
- • No structural coverage evidence
- • Disconnected test reports across 3 tools
VAfter ESL
- • CycloneDX SBOM with VEX decisions generated by SBOMator™
- • All CVEs triaged: 12 remediated, 8 documented with compensating controls
- • 12 real defects fixed by ESL engineers; 328 false positives filtered
- • 87% branch coverage with risk-based justification for uncovered code
- • Full traceability in Polarion ALM via Parasoft Test Tool Suite Connector
Result: FDA 510(k) clearance achieved with zero software evidence deficiencies flagged in the substantive review.
Bring ESL the software - not a cleaned-up demo
We will build, clean and connect the evidence. Start with a software evidence scoping workshop.
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