FDA.reportPublic FDA data

KOWA AP-7000

Primary DI
04987646805113
Brand
KOWA AP-7000
Company
KOWA COMPANY,LTD.
Model
FT10K
Device description
KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results.Static quantitative perimetry examinations and kinetic perimetry examinations are available.
Published
2019-01-08
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
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
04987646805113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987646805113049876468051134987646805113

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth430Millimeter
Height700Millimeter
Weight26Kilogram
Width730Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692281073
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987646807575KOWA nonmyd 8K9L61K2016-09-16
04987646810476KOWA SL-19SL192BK/W2024-10-08
04987646810223KOWA SL-19SL191BK/W2023-01-10
04987646810032KOWA SL-19SL191K/W2022-12-07
04987646810049KOWA SL-19SL191K/A2022-12-07
04987646810056KOWA SL-19SL191K/G2022-12-07
04987646810063KOWA SL-19SL191K/P2022-12-07
04987646810070KOWA SL-19SL191K/B2022-12-07
04987646804031KOWA SL-15SL150K2016-09-16
04987646806905KOWA SL-17SL170K/W2016-09-16
04987646806912KOWA SL-17SL170K/A2016-09-16
04987646806929KOWA SL-17SL170K/G2016-09-16
04987646806936KOWA SL-17SL170K/P2016-09-16
04987646809128KOWA nonmyd AFK9L64K2020-01-15
04987646807728KOWA DR-1αDE2K2019-06-10
04987646808923KOWA VK-2sVK28K2019-06-10
04987646808930KOWA VK-2sVK28UE2019-06-10
04987646808947KOWA VK-2sVK28U2E2019-06-10
04987646800583KOWA GENESIS-DfK9L51BK2016-09-16
04987646800606KOWA nonmyd a-DIIIK9L58K2018-02-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975449020053SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
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
07649990085036VisionOnePeriVision SAHPT2024-02-28
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