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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;
• FDA-approved IDE Category B devices; and
• Hospital Institutional
Review Board (IRB) approved
Look up any company at the FDA website http://www.accessdata.fda.gov/
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 low price digital imaging solution for mydriatic fundus cameras.
New Vision Ophthalmic Medical Imaging Software...