FDA.reportPublic FDA data

MAIA

Primary DI
08053677040024
Brand
MAIA
Company
CENTERVUE SPA
Model
MAIA
Catalog number
ATMARME002
Device description
MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.
Published
2016-07-29
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
HPTPerimeter, Automatic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153181000MAIACentervue S.P.A.2016-06-08MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053677040024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053677040024080536770400248053677040024

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

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
08053677040093EIDONEIDON FAAPFLAOP1002018-07-23
08053677040116DRSplusDRSplus2019-12-09
08053677040048COMPASSCOMPASS AMGSDME012016-08-03
08053677040055MAIAS-MAIAACMASME0022016-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06975449020060S4OPTIKChongQing SS Medical Equipments Co., LtdHPT2026-05-14
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2026-01-14
00860011691761Radius InspireRadiusXR, Inc.HPT2025-09-22
G617RVF2001RetinaLogikRetinalogik Inc.HPT2025-03-07
00860010709719Virtual Eye PROVirtual Vision HealthHPT2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHPT2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHPT2024-12-16
G617RVF1001RetinaLogikRetinalogik Inc.HPT2024-12-02
00860010709788Virtual Eye SoftwareVirtual Vision HealthHPT2024-11-27
07649990085074VisionOnePeriVision SAHPT2024-10-14
00860010709757Virtual Eye SoftwareVirtual Vision HealthHPT2024-08-20
04582275270075NAKONAN MEDICAL USA, INC.HPT2024-08-02
00860010709740Virtual Eye SoftwareVirtual Vision HealthHPT2024-05-07
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00860010709733Virtual Eye SoftwareVirtual Vision HealthHPT2024-02-27
00860001720433Virtual FieldVirtual Field, Inc.HPT2023-11-08
00853569007108PalmScan VF2000Micro Medical Devices, Inc.HPT2023-08-16
00853569007122PalmScan DA2000Micro Medical Devices, Inc.HPT2023-08-16
00860010599709Vision Restoration TherapyNovavision, Inc.HPT2023-07-03
04573277310111imovifaCREWT MEDICAL SYSTEMS, INC.HPT2023-06-16
04987669101544MICROPERIMETERNIDEK CO.,LTD.HPT2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.HPT2023-06-12
08800019600824Automated Perimetery HVF-100 Huvitz Co., Ltd.HPT2023-06-12
00860008686015VisuALL VRP ETSOlleyes, Inc.HPT2023-04-26
00860008686022VisuALL VRP SOlleyes, Inc.HPT2023-04-26
00860001720402Virtual FieldVirtual Field, Inc.HPT2023-01-23
00860001720426Virtual FieldVirtual Field, Inc.HPT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HPT2023-01-23