FDA.reportPublic FDA data

MAIA

Primary DI
08053677040130
Brand
MAIA
Company
CENTERVUE SPA
Model
MAIA3
Catalog number
AHMACME001
Device description
MAIA is a peripheral vision analyser, intended for measuring retinal sensitivity, fixation stability and locus fixation as well as to acquire and review retinal images with or without a mydriatic agent and for their review.
Published
2026-04-29
Public version status
New
Distribution status
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
K243504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243504000MAIA (AHMACME001)Centervue S.P.A.2025-03-17MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053677040130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053677040130080536770401308053677040130

GMDN Terms#

Term, Definition table
TermDefinition
Perimeter, automaticA mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.

Regulatory Flags#

DUNS number
338702316
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053677040123EIDONEIDON UWF ModuleAXWFLME0012026-04-29
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
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
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
04059237000396SPECTRALIS, HEPHeidelberg Engineering GmbHMYC2018-07-11