Image filing software NAVIS-EX

Basic Information

• Brand Name: Image filing software NAVIS-EX
• Primary DI: 04987669200636
• Version / Model: 1.12
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: 39e20634-d95f-46d9-90d7-fc35645c10db

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NFG	Device, Communications, Images, Ophthalmic	Radiology	892.2020	1
NFF	Device, Storage, Images, Ophthalmic	Radiology	892.2010	1
MYC	Ophthalmoscope,Laser,Scanning	Ophthalmic	886.1570	2
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	886.1605	1
OBO	Tomography, Optical Coherence	Ophthalmic	886.1570	2
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	886.1850	2
NFJ	System, Image Management, Ophthalmic	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45724	Eye anterior segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior segment of the eye (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an eye anterior segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active
52748	Posterior eye segment analyser software	An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669200636	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]