Ophthalmic Imaging Systems
Country not established
- Devices
- 5
What Ophthalmic Imaging Systems makes
Ophthalmic Imaging Systems manufactures portable and modular retinal imaging devices, including the EYESCAN system for comprehensive eye examinations, the WINSTATION Retinal Imager for high-resolution retinal scans, and the SYMPHONY Image Management System for digital image storage and retrieval. Their portfolio also includes standalone digital imaging systems (DFC-1024 and DFC-512) and the GLAUCOMA-SCOPE, designed for glaucoma assessment.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory compliance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Winstation Retinal Imager Ref K982689
Regimes: 510(k) Registry: 510(k)Ois Symphony Image Managment System Ref K110006
Regimes: 510(k) Registry: 510(k)Dfc-1024 & Dfc-512 Digital Imaging System Ref K913929
Regimes: 510(k) Registry: 510(k)Glaucoma-Scope Ref K913118
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ophthalmic Imaging Systems have in the registry?
The registry currently lists 5 devices for Ophthalmic Imaging Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ophthalmic Imaging Systems's devices?
Among its 5 most recently registered devices, Ophthalmic Imaging Systems has devices listed in FDA 510(k) (5 devices).
What risk classes do Ophthalmic Imaging Systems's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Ophthalmic Imaging Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ophthalmic Imaging Systems in the registry?
The most recently registered devices listed for Ophthalmic Imaging Systems include OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN, WINSTATION RETINAL IMAGER, OIS SYMPHONY IMAGE MANAGMENT SYSTEM and DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM.