K242522
- 510(k) number
- K242522
- Device name
- Second Opinion CC
- Applicant
- Pearl, Inc. CA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-01-16
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242522.pdf
Official FDA record: K242522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.