DEVICE: NON-MYDRIATIC AUTO FUNDUS CAMERA (04987669100554)

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Device Identifier (DI) Information

NON-MYDRIATIC AUTO FUNDUS CAMERA
AFC-330

NIDEK CO.,LTD.
04987669100554
GS1
1
The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ophthalmic fundus camera An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.
Anterior eye segment analysis system application software An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, mark-up, processing and analysis capabilities to an anterior eye segment analysis system or system analyser. A basic set of applications programs and routines are included with such systems and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software can be installed in the integrated analyser computer and/or a computer workstation (e.g., an off-the-shelf desktop or laptop computer).
Posterior eye segment analysis system application software An individual software application program or group of programs that add specific computer assisted display, mark-up, processing and analysis capabilities to a posterior eye segment analysis system or system analyser. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It will typically have a documentation module, a viewer for consultation, and configured to process images (e.g., photographs and angiograms) of the posterior pole which aids in the identification of changes displayed in a series over time. It may also be used in an off-the-shelf desktop or laptop computer.
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FDA Product Code

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Product Code Product Code Name
HKI Camera, Ophthalmic, Ac-Powered
NFF Device, Storage, Images, Ophthalmic
NFG Device, Communications, Images, Ophthalmic
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
June 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
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No CLOSE

Customer Contact

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1-800-223-9044
info@nidek.com
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