K242437
- 510(k) number
- K242437
- Device name
- Smile Dx®
- Applicant
- Cube Click, Inc. NY · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-05-14
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242437.pdf
Official FDA record: K242437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.