K232555
- 510(k) number
- K232555
- Device name
- Harmony
- Applicant
- Topcon Healthcare Solutions NJ · US
- Product code
- NFJ — System, Image Management, Ophthalmic
- Decision date
- 2023-11-20
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232555.pdf
Official FDA record: K232555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.