FDA.reportPublic FDA data

EIDON

Primary DI
08053677040062
Brand
EIDON
Company
CENTERVUE SPA
Model
RETIA
Catalog number
AINEUME001
Device description
RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluorescence images of the retina.
Published
2016-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYCOphthalmoscope,Laser,Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYCOphthalmoscope, Laser, ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142047000EIDONCentervue S.P.A.2014-11-12MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053677040062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053677040062080536770400628053677040062

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
08053677040079EIDONEIDON AFAIFLUME0012016-07-29
08053677040086RETIA 2RETIA 2AINEUME0022017-07-15
08053677040093EIDONEIDON FAAPFLAOP1002018-07-23
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
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.MYC2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.MYC2023-06-12
04059237000884SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000815SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
00849233012066Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
10849233012063Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
04059237000464SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
04059237000488SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
08053677040116DRSplusCENTERVUE SPAMYC2019-12-09
04059237000716SPECTRALISHeidelberg Engineering GmbHMYC2019-10-29
05057056107509OCT Ophthalmoscope OPTOS PUBLIC LIMITED COMPANYMYC2019-10-29
04059237000570SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000594SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000211SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000501SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000525SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000549SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
08053677040093EIDONCENTERVUE SPAMYC2018-07-23
04059237000341SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11
04059237000358SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11