FDA.reportPublic FDA data

AUTO CHART PROJECTOR ACP-8

Primary DI
04562123289206
Brand
AUTO CHART PROJECTOR ACP-8
Company
TOPCON CORPORATION
Model
ACP-8
Published
2022-08-31
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
HOSProjector, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOSProjector, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562123289206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562123289206045621232892064562123289206

GMDN Terms#

Term, Definition table
TermDefinition
Visual acuity projectorA mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
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
04562123288315SPECULAR MICROSCOPE SP-1PSP-1P2016-09-19
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000MC-5S2025-12-09
04560126269188AUTO KERATO-REFRACTOMETER KR-1KR-12025-11-21
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATRK-32025-11-17
04560126269140AUTO KERATO-REFRACTOMETER KR-800KR-8002025-10-31
04560126269164AUTO REFRACTOMETER RM-800RM-8002025-10-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)3D OCT-12025-09-11
04571130283381AUTO KERATO-REFRACTOMETER KR-1KR-12025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PAKR-800PA2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosSNi-12025-05-01
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000SNi-12025-02-27
04571130283367AUTO KERATO-REFRACTOMETER KR-800AKR-800A2025-04-15
04562123288179COMPUTERIZED TONOMETER CT-80CT-802016-09-19
04560126268532COMPU VISION CV-5000CV-50002025-02-27
04560126268549COMPU VISION CV-5000CV-50002025-02-27
045601262685701DIAL CONTROLLER KB-50SKB-50S2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04571130282773REFRACTION SYSTEM ChronosChronos2024-08-01
04571130283350AUTO KERATO-REFRACTOMETER KR-800KR-8002024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03615020000113CP 550ESSILOR INTERNATIONALHOS2026-02-23
00850053428500VisiChartTOPCON HEALTHCARE INCHOS2023-06-20
04560323640902TAKAGITAKAGI SEIKO CO.,LTD.HOS2023-06-09
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