FDA.reportPublic FDA data

Chart Projector HCP-7000

Primary DI
08800019600237
Brand
Chart Projector HCP-7000
Company
Huvitz Co., Ltd.
Model
HCP-7000
Catalog number
HCP-7000
Device description
chart projector is intended to be used to check eye optometry
Published
2019-05-10
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
HOSProjector, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOSProjector, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019600237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600237088000196002378800019600237

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

Contacts#

Phone, Email table
PhoneEmail
+82314289100svc@huvitz.com

Regulatory Flags#

DUNS number
688154202
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
08800019600121Imaging System HIS-5000UHIS-5000UHIS-5000U2019-05-10
08800019600954Vision ScreenerHVS-12026-02-13
08800019600992Auto Ref-Topographer HRKT-1HRKT-12026-01-30
08800019601074Visual Acuity Chart System HDC-100HDC-1002025-11-19
08800019601005LilivisLS-100-TIP-3R2025-09-08
08800019600794Huvitz Integrated Image Server HIIS-1HIIS-12025-08-14
08800019600961OCTiX IntraOral ScannerLSO-100Y4XXCL-24-000012024-11-26
00880019600961Lilivis SCAN OPTOMOLSO-100Y4XXCL-24-000012024-11-26
08800019600978Instrument Table CIT-4100CIT-41002024-06-24
08800019600985Instrument Table CIT-4200CIT-42002024-06-24
08800019600893Lilivis Scan LS-100LS-100LS-1002024-05-27
08800019600909Lilivis CAD L-CADL-CADLS-1002024-05-27
08800019600411Applanation Tonometer HT-5000HT-5000HT-50002023-06-12
08800019600787Optical Biometer HBM-1HBM-12023-10-18
08800019600916Digital Refractor HDR-7100PHDR-7100P2023-08-24
08800019600923Auto Ref/Keratometer HRK-8100AHRK-8100A2023-08-24
08800019600435Non-contact Tonometer HNT-1PHNT-1PHNT-1P2023-06-12
08800019600503Ref-Keratometer ERK-9100ERK-9100ERK-91002023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHTR-1AHTR-1A2023-06-12
08800019600732Digital Chart HDC-9100NHDC-9100NHDC-9100N2023-06-12

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
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
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