October 2012 -
University of Wisconsin - Madison Fundus Photograph Reading Center
(FPRC) approves Fundus Photo for study use
November 2012 - Press Release
Fundus Photo Digital Upgrades for Fundus Cameras
April 2013 - Fundus Autofluoresence -
Fundus Autofluorescence (4 mb)
October 2013 -
Duke University Reading Center approves Fundus Photo for study use
2013 - DARC Reading Center approves Fundus Photo for study use
Fundus Photo has US FDA 510(k) clearance
We are the only ophthalmic digital imaging provider in this segment to acheive
the highest level of quality, safety and performance the US FDA and ISO
All devices, attachments or software used for diagnosis and/or
treatment are required to have FDA
clearance for commercial distribution in the US.
Did you know...
Medicare requires FDA
approved devices for payment and
FDA reports all device approvals to CMS?
Medicare Benefit Policy Manual, Chapter 14 -
Medical Devices, sections 10 & 80
that may be covered under Medicare include the following categories:
by the FDA through
the Pre-Market Approval (PMA) process;
Devices cleared by the
FDA through the 510(k) process;
IDE Category B devices;
• Hospital Institutional
Review Board (IRB) approved
related to the use of a non-covered device are
not covered under Medicare.
Look up any company at the FDA website
Topcon, Zeiss, Escalon, OIS,
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 available for your mobile
device - www.fundusphoto.mobi
- give it a try!
Fundus Photo unveils it's
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