K243893
- 510(k) number
- K243893
- Device name
- Second Opinion® Pediatric
- Applicant
- Pearl, Inc. CA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-05-05
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243893.pdf
Official FDA record: K243893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.