K232828
- 510(k) number
- K232828
- Device name
- IMAGEnet6 Ophthalmic Data System
- Applicant
- Topcon Corporation JP
- Product code
- NFJ — System, Image Management, Ophthalmic
- Decision date
- 2024-03-01
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K232828.pdf
Official FDA record: K232828
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.