We are approved for studies with all of the major reading centers, including, but not limited to:


FPRC – University of Wisconsin, Madison – Fundus Photograph Reading Center 

DARC – New York – The Digital Angiography Reading Center

Duke University Fundus Reading Center

DIRC – Doheny Image Reading Center

DRCRnet – Diabetic Retinopathy Clinical Research Network 

Images for reading centers may be exported as jpg or png format,
and as anonymous for either.

Fundus Photo has US FDA 510(k) clearance.

We are the only ophthalmic digital imaging manufacturer in this segment to achieve the highest level of quality, safety and performance the US FDA, CE and ISO require.

Did you know…
Medicare requires FDA approved devices for payment and FDA reports all device approvals to CMS?

All devices, attachments or software used for diagnosis and/or treatment are required to have FDA clearance for commercial distribution in the US.

Medicare Benefit Policy Manual, Chapter 14 – Medical Devices, sections 10 & 80  https://www.cms.gov/manuals/downloads/bp102c14.pdf
Devices that may be covered under Medicare include the following categories:• Devices approved by the FDA through the Pre-Market Approval (PMA) process;

• Devices cleared by the FDA through the 510(k) process;

• FDAapproved IDE Category B devices; and

• Hospital Institutional Review Board (IRB) approved IDE devices 

Services related to the use of a non-covered device are not covered under Medicare.

Look up any company at the FDA website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Topcon, Zeiss, Escalon, Kowa, Nidek, Canon and Fundus Photo all have FDA clearance and may legally market their imaging products (hardware and software) in the US.

Fundus Photo unveils it’s low price digital imaging solution for mydriatic fundus cameras.

New Vision Ophthalmic Medical Imaging Software…

Fundus Photo is the exclusive dealer for North America, South America and Central America





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