FDA.reportPublic FDA data

Visual Chart System

Primary DI
08800074500046
Brand
Visual Chart System
Company
VIEW-M TECHNOLOGY CO., LTD.
Model
SCS-3200
Catalog number
SCS-3200
Published
2023-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800074500046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800074500046088000745000468800074500046

GMDN Terms#

Term, Definition table
TermDefinition
Visual acuity light boxA mains electricity (AC-powered) light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) imprinted with block letters (optotypes) and/or other symbols (e.g., LEA symbols for children who can not read) in gradually decreasing sizes used for testing visual acuity. The letters/symbols are identified according to distances at which they are ordinarily visible (normally 6 metres or 20 feet) and are combined in a box where the individual letters or symbols are selected and high-lighted by the optician/doctor with background electrical lighting. This device is typically mounted on a wall of the optician/doctor's examination room/office.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827077305148sell@viewmtechnology.com

Regulatory Flags#

DUNS number
557821283
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
08800074500008Visual Chart SystemVLC-1900VLC-19002024-03-25
08800074500015Visual Chart SystemVLC-1900PVLC-1900P2024-03-25
08800074500022Visual Chart SystemVLC-2400VLC-24002024-03-25
08800074500039Visual Chart SystemVLC-2400PVLC-2400P2024-03-25
08800074500114Visual Chart SystemCSPOLA600CSPOLA6002024-03-25
08800074500190Self Vision TesterVAA-2000PSEVAA-2000PSE2024-03-25
08800074500213Self Vision TesterVAA-2000PCEVAA-2000PCE2024-03-25
08800074500282Visual Chart SystemCS550CS5502024-03-25
08800074500299Visual Chart SystemCSPOLA600CCSPOLA600C2024-03-25
08800074500305Visual Chart SystemCSPOLA600FCSPOLA600F2024-03-25
08800074500244Auto LensmeterVLM-2400VLM-24002023-01-10
08800074500251Auto LensmeterALM-1PALM-1P2023-01-10
08800074500152LCD ACUITY DEVICEPROVUEPROVUE2020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000TOPCON CORPORATIONHOX2025-12-09
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
04540008310580RexxamREXXAM CO., LTD.HOX2025-10-17
04540008310610RexxamREXXAM CO., LTD.HOX2025-10-17
00812559012003NearBrightREICHERT, INC.HOX2025-08-12
00812559012010NearBrightREICHERT, INC.HOX2025-08-12
00812559012201ClearChart4REICHERT, INC.HOX2025-08-12
00812559012225ClearChart4XREICHERT, INC.HOX2025-08-12
00812559012232ClearChart4PREICHERT, INC.HOX2025-08-12
B43050085500GoCheck KidsGobiquity, Inc.HOX2025-03-20
08034028770562TOPCONVISIA IMAGING SRLHOX2025-02-20
B43071000020GoCheck MultiScreenerGobiquity, Inc.HOX2024-09-23
06971922133234YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2024-08-08
B43050085440GoCheck KidsGobiquity, Inc.HOX2024-07-26
B43071000010GoCheck KidsGobiquity, Inc.HOX2024-07-26
08800074500008Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500015Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500022Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500039Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500114Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500190Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500213Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500282Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25