K233561
- 510(k) number
- K233561
- Device name
- 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
- Applicant
- Topcon Corporation JP
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-04-10
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233561.pdf
Official FDA record: K233561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.