K241081
- 510(k) number
- K241081
- Device name
- 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
- Applicant
- Topcon Corporation JP
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-07-17
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K241081.pdf
Official FDA record: K241081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.