FDA.reportPublic FDA data

Visual Chart System

Primary DI
08800074500022
Brand
Visual Chart System
Company
VIEW-M TECHNOLOGY CO., LTD.
Model
VLC-2400
Catalog number
VLC-2400
Device description
VLC-2400 is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for VLC-2400 can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-2400 is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800074500022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800074500022088000745000228800074500022

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

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
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
08800074500046Visual Chart SystemSCS-3200SCS-32002023-03-08
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
B43050086100GoCheck KidsGobiquity, Inc.HOX2026-09-30
B43050086010GoCheck KidsGobiquity, Inc.HOX2026-06-25
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
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