K243504
- 510(k) number
- K243504
- Device name
- MAIA (AHMACME001)
- Applicant
- Centervue S.P.A. IT
- Product code
- MYC — Ophthalmoscope, Laser, Scanning
- Decision date
- 2025-03-17
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243504.pdf
Official FDA record: K243504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.