FDA.reportPublic FDA data

Humphrey Field Analyzer 3 (HFA3)

Primary DI
04057748085246
Brand
Humphrey Field Analyzer 3 (HFA3)
Company
Carl Zeiss Meditec, Inc.
Model
830
Device description
The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, monitoring and assisting in the diagnosis of ocular and neurological disorders including glaucoma.
Published
2017-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPTPerimeter, Automatic, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057748085246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057748085246040577480852464057748085246

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362747011
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057748087141CIRRUS HD-OCT 60002019-11-01
04057748087080CIRRUS HD-OCT50002016-04-15
04057748087097CIRRUS HD-OCT5002016-08-25
04057748087127CIRRUS HD-OCTCIRRUS Review Software2017-04-14
04057748096044CLARUS7002019-07-01
04057748085284Humphrey Field Analyzer 3 (HFA3) HFA3 Review Software2019-03-22
04057748096037CLARUS5002017-09-25
04057748096051CLARUSCLARUS Review Software 2017-09-25
04057748087110PLEX Elite90002017-04-14
04057748081118ATLAS Corneal Topography System90002018-06-13
04057748085215Humphrey FDT7102018-06-13
04057748085239Humphrey Matrix 8002018-06-13
04057748085253Humphrey Field Analyzer 3 (HFA3)8402017-01-11
04057748085260Humphrey Field Analyzer 3 (HFA3)8502017-01-11
04057748085277Humphrey Field Analyzer (HFA3)8602017-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860010709795Virtual Eye SoftwareVirtual Vision HealthHPT2024-12-16
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04582275270075NAKONAN MEDICAL USA, INC.HPT2024-08-02
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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