FDA.reportPublic FDA data

Automated Perimeter

Primary DI
05903293141120
Brand
Automated Perimeter
Company
OPTOPOL TECHNOLOGY SP Z O O
Model
PTS 920
Catalog number
760-001
Device description
The PTS 920 automated perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.
Published
2018-03-09
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903293141120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903293141120059032931411205903293141120

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
522052554
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903293141113Automated Projection PerimeterPTS 2000770-0012018-03-09
05903293141137Automated PerimeterPTS 920BY760-0022018-03-09
05903293141144Automated PerimeterPTS 925765-0032018-03-09
05903293141151Automated PerimeterPTS 925W765-0012018-03-09
05903293141168Automated PerimeterPTS 925BY765-0022018-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975449020015SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
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