FDA.reportPublic FDA data

Image filing software NAVIS-EX

Primary DI
04987669200636
Brand
Image filing software NAVIS-EX
Company
NIDEK CO.,LTD.
Model
1.12
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 clientPC.
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered
HKICamera, Ophthalmic, Ac-Powered
HPTPerimeter, Automatic, Ac-Powered
MYCOphthalmoscope,Laser,Scanning
NFFDevice, Storage, Images, Ophthalmic
NFGDevice, Communications, Images, Ophthalmic
NFJSystem, Image Management, Ophthalmic
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1
MYCOphthalmoscope, Laser, ScanningOphthalmic2
NFFDevice, Storage, Images, OphthalmicRadiology1
NFGDevice, Communications, Images, OphthalmicRadiology1
NFJSystem, Image Management, OphthalmicRadiology2
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669200636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669200636049876692006364987669200636

GMDN Terms#

Term, Definition table
TermDefinition
Eye anterior segment analyser softwareAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31

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06975449020060S4OPTIKChongQing SS Medical Equipments Co., LtdHPT2026-05-14
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
08053677040512iCare ALTIUS CWCENTERVUE SPANFJ2026-04-29
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
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00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
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05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
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08034028770517ESSILORVISIA IMAGING SRLHKI2024-11-04
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04