K232944
- 510(k) number
- K232944
- Device name
- CALLISTO eye
- Applicant
- Carl Zeiss Meditec, AG CA · US
- Product code
- NFJ — System, Image Management, Ophthalmic
- Decision date
- 2023-12-21
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232944.pdf
Official FDA record: K232944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.