# Carl Zeiss Jena GmbH

- Location (FDA's records): Washington, DC
- FDA decisions: 1 (2001–2001): 1 510(k) clearance
- Product codes: HKI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Optical Imaging, Ltd.: 1 (https://510kreport.com/company/optical-imaging)
- Nidek Technologies Srl: 1 (https://510kreport.com/company/nidek-technologies)
- Od-Os GmbH: 1 (https://510kreport.com/company/od-os)
- Opto Global, Inc.: 1 (https://510kreport.com/company/opto-global)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Carl Zeiss Ophthalmic Systems, Inc.: 1 (https://510kreport.com/company/carl-zeiss-ophthalmic-systems)
- Imedos GmbH: 1 (https://510kreport.com/company/imedos)
- Visual Pathways, Inc.: 1 (https://510kreport.com/company/visual-pathways)

## Its most-cited devices
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System (2001), cited by 8

## Recent decisions
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System (Sep 26, 2001)

Source page: https://510kreport.com/company/carl-zeiss-jena