Nidek AFC-330 Automated Fundus Camera Cleared in U.S.

Nidek AFC-330 Automated Fundus Camera Cleared in U.S.

FREMONT, Calif. and JACKSONVILLE, Fla., May 15, 2012 (GLOBE NEWSWIRE) — NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces the FDA 510(k) Clearance for the AFC-330, their most automated fundus camera yet.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12900

“The AFC-330 represents NIDEK’s 3rd generation of automated fundus camera. We are both proud and excited to be leading the way designing and producing fundus cameras that are faster, easier, and more versatile than ever. We anticipate increasing our fundus camera market share with our market expansion with MARCO Ophthalmic.”

Motoki Ozawa, President and CEO of NIDEK

“We couldn’t be more excited about adding the Nidek AFC-330 automated fundus camera to our full product line of diagnostic technologies. The AFC-330 fits perfectly into Marco’s successful model of increasing efficiency with the kind of powerful, easy-to-use, and high-quality instrumentation that our customers have come to expect.”

David Marco, President and CEO of MARCO

The AFC-330 makes quantum leaps improving the operator and patient interface, simplicity, automation, and total practice efficiencies. This camera offers an all in one compact design, auto alignment on the X-Y-Z axis, and a wide range of automated features including auto stereo for Glaucoma Management. The lower flash intensity and sound-dampening internal movements mean less retakes and improved patient comfort. No other Non-Mydriatic camera provides both this level of advanced automation and image quality.

While NIDEK will continue to sell to the Ophthalmology market in the United States, MARCO, the leader in Vision Diagnostics, will sell the NIDEK AFC-330 to the Optometry market. This market expansion is to increase the distribution channels and better serve new and existing customers for both companies.

About NIDEK:

Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

The Nidek Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=1006

About MARCO:

Founded in Jacksonville, FL, in 1967, MARCO continues to expand its position as ‘The Leader in Vision Diagnostics’ with a product line that encompasses classical lane equipment and NIDEK high-tech, automated refractive and retinal instrumentation. MARCO continues to provide unparalleled training and support to its expanding United States customer base.

Features

All in one with built-in camera and computer

Five automated functions for enhanced ease-of-use

Monitor and indicator for operator assist

Navigation of stereo and panorama photography

Low flash intensity and quiet shutter sound

NIDEK (Gamagori, Japan) has received FDA clearance to market its AFC-330 fundus camera in the U.S. The unit is an all-in-one system that contains both the camera and the processing computer, negating the need for another machine to remain nearby.

The device is the company’s most automated model, and features automatic alignment along the three axis, uses a lower brightness flash, and has dampened mechanical components, among other advances.

More details about the AFC-330 from the product page:

All in one with built-in camera and computer

The AFC-330 has an integrated CCD camera and microcomputer in one compact unit without requiring an external camera and PC. It is virtually “ready to use out of the box”.

Five automated functions for enhanced ease-of-use

With five automated functions – 3-D auto tracking, auto focus, auto switching from anterior eye to fundus, auto shot, and auto print / export – the AFC-330 enables seamless photography from start to finish.

Monitor and indicator for operator assist

The anterior eye monitor allows an operator to constantly verify alignment. The focus split indicator shows the amount of focus deviation in the fundus observation screen.

Navigation of stereo and panorama photography

The AFC-330 navigates stereo and panorama photography with target marks displayed on observation screen.

Low flash intensity and quiet shutter sound

The AFC-330 reduces flash intensity by 40% and sound of the shutter by 50% compared to its predecessor, the AFC-230 / 210.

Source : http://www.globenewswire.com/newsroom/news.html?d=256233

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