K231222
- 510(k) number
- K231222
- Device name
- 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
- Applicant
- Topcon Corporation JP
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2023-10-30
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231222.pdf
Official FDA record: K231222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.