DEVICE: Image filing software (04987669100523)

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Device Identifier (DI) Information

Image filing software
NAVIS-EX

NIDEK CO.,LTD.
04987669100523
GS1
1
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client 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
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
NFG Device, Communications, Images, Ophthalmic
NFF Device, Storage, Images, Ophthalmic
MYC Ophthalmoscope,Laser,Scanning
HKI Camera, Ophthalmic, Ac-Powered
HPT Perimeter, Automatic, Ac-Powered
OBO Tomography, Optical Coherence
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Sterilization

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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
August 26, 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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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