K242600
- 510(k) number
- K242600
- Device name
- Second Opinion Periapical Radiolucency Contours
- Applicant
- Pearl, Inc. CA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-04-11
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242600.pdf
Official FDA record: K242600
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.