FDA.reportPublic FDA data

EIDON

Primary DI
08053677040093
Brand
EIDON
Company
CENTERVUE SPA
Model
EIDON FA
Catalog number
APFLAOP100
Device description
The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.
Published
2018-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
MYCOphthalmoscope, Laser, Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
MYCOphthalmoscope, Laser, ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180526000EIDON FACentervue S.P.A.2018-07-16MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053677040093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053677040093080536770400938053677040093

GMDN Terms#

Term, Definition table
TermDefinition
Scanning-laser ophthalmic imaging systemAn assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338702316
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053677040123EIDONEIDON UWF ModuleAXWFLME0012026-04-29
08053677040130MAIAMAIA3 AHMACME0012026-04-29
08053677040512iCare ALTIUS CWiCare ALTIUS CWBACW0000102026-04-29
08053677040017DRSDRS2016-07-29
08053677040031EIDONEIDONAMFUNME012016-07-29
08053677040062EIDONRETIAAINEUME0012016-08-03
08053677040079EIDONEIDON AFAIFLUME0012016-07-29
08053677040086RETIA 2RETIA 2AINEUME0022017-07-15
08053677040116DRSplusDRSplus2019-12-09
08053677040024MAIAMAIAATMARME0022016-07-29
08053677040048COMPASSCOMPASS AMGSDME012016-08-03
08053677040055MAIAS-MAIAACMASME0022016-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857253006085Phoenix ICON GO Control BoxPhoenix ClinicalHKI2026-05-14
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
00857253006019ICON HandpiecePhoenix ClinicalHKI2026-04-03
00857253006033FA ModulePhoenix ClinicalHKI2026-04-03
00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011641RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011924RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
06430046261006Optomed Smartscope FAOptomed OyHKI2025-12-12
06430046260597Smartscope Pro full setOptomed OyHKI2025-11-13
06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
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00860010658109Fundus PhotoFundus PhotoHKI2025-03-31
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCHKI2025-02-24
00852788008019NeolightNEOLIGHT LLCHKI2025-01-26
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00852788008040NeolightNEOLIGHT LLCHKI2025-01-26
00852788008057NeolightNEOLIGHT LLCHKI2025-01-26