# Ophthalmic Imaging Systems

- Location (FDA's records): Sacramento, CA
- FDA decisions: 5 (1991–2011): 5 510(k) clearances
- Product codes: HKI (3), HLI (1), NFJ (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Topcon Corporation: 1 (https://510kreport.com/company/topcon)
- Medivision Medical Imaging, Ltd.: 1 (https://510kreport.com/company/medivision-medical-imaging)
- Haag-Streit AG: 1 (https://510kreport.com/company/haag-streit)
- Keeler Instruments, Inc.: 1 (https://510kreport.com/company/keeler-instruments)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Topcon Medical Systems, Inc.: 1 (https://510kreport.com/company/topcon-medical-systems)

## Firms that cite its devices most
- Talia Technology, Ltd.: 1 (https://510kreport.com/company/talia-technology)
- Mrp Group, Inc.: 1 (https://510kreport.com/company/mrp-group)
- Zeta Development Laboratories: 1 (https://510kreport.com/company/zeta-development-laboratories)
- Tomey Corporation USA: 1 (https://510kreport.com/company/tomey-usa)
- Marcher Enterprises, Ltd.: 1 (https://510kreport.com/company/marcher-enterprises)
- Centervue S.P.A.: 1 (https://510kreport.com/company/centervue)

## Its most-cited devices
- K913929: DFC-1024 & DFC-512 Digital Imaging System (1991), cited by 4
- K913118: Glaucoma-Scope (1991), cited by 1
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (2009), cited by 1
- K982689: Winstation Retinal Imager (1998), cited by 1

## Recent decisions
- K110006: Ois Symphony Image Managment System (May 18, 2011)
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (Nov 17, 2009)
- K982689: Winstation Retinal Imager (Oct 23, 1998)
- K913929: DFC-1024 & DFC-512 Digital Imaging System (Nov 27, 1991)
- K913118: Glaucoma-Scope (Oct 9, 1991)

Source page: https://510kreport.com/company/ophthalmic-imaging-systems