FDA.reportPublic FDA data

VisiChart

Primary DI
00850053428500
Brand
VisiChart
Company
TOPCON HEALTHCARE INC
Model
VisiChart II
Device description
Visual Acuity Chart
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOSProjector, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOSProjector, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053428500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053428500008500534285008500534285000850053428500

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053547238
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003069791OC-230024045-OX-L1-0002026-10-19
00850003069784OC-230024045-WT-L1-0002026-08-18
00850003069777OC-230024045-WT-L2-0002026-08-03
00850003069753OC-230024045-HG-L1-0002026-05-06
00850003069760OC-230024045-HG-H1-0002026-05-06
00850003069739OC-240024048-WT-L1-0002026-03-13
00850003069630OC-220024046-PL-H2-0002025-10-31
00850003069647OC-220024046-PL-L2-0002025-10-31
00850003069654OC-220024046-TL-H1-0002025-10-31
00850003069661OC-220024046-TL-L1-0002025-10-31
00850003069678OC-220024046-TL-H2-0002025-10-31
00850003069685OC-220024046-TL-L2-0002025-10-31
00850003069692OC-220024046-WT-H1-0002025-10-31
00850003069708OC-220024046-WT-L1-0002025-10-31
00850003069715OC-220024046-WT-H2-0002025-10-31
00850003069722OC-220024046-WT-L2-0002025-10-31
00850053428746OC-220024046-AU-H1-0002025-10-31
00850053428753OC-220024046-AU-L1-0002025-10-31
00850053428760OC-220024046-AU-H2-0002025-10-31
00850053428777OC-220024046-AU-L2-0002025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038195632Eli EzerU.S. OPHTHALMIC, L.L.C.HOS2026-10-29
00850038195601Eli EzerU.S. OPHTHALMIC, L.L.C.HOS2026-10-19
03615020000113CP 550ESSILOR INTERNATIONALHOS2026-02-23
04560323640902TAKAGITAKAGI SEIKO CO.,LTD.HOS2023-06-09
04562123289206AUTO CHART PROJECTOR ACP-8TOPCON CORPORATIONHOS2022-08-31
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCHOS2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCHOS2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCHOS2022-07-06
00813125016838Head-Up-Display, HUD-1IRIDEX CORPORATIONHOS2021-12-05
08809358430314Medizs Auto Chart Projector CP-11MEDIZS Inc.HOS2021-03-23
06971821404015Auto chart projectorNingbo Ming Sing Optical R & D Co., Ltd.HOS2020-08-05
08800019600220Chart Projector CCP-3100Huvitz Co., Ltd.HOS2019-05-10
08800019600237Chart Projector HCP-7000Huvitz Co., Ltd.HOS2019-05-10
06945033902058TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HOS2018-09-24
06945033902065TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HOS2018-09-24
00855005006218Head-Up-Display, HUD-1TOPCON MEDICAL LASER SYSTEMS, INC.HOS2018-02-12