SYSTEM CHART

Basic Information

• Brand Name: SYSTEM CHART
• Primary DI: 04987669100653
• Version / Model: SC-1600
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 2
• Public Version Date: 2019-07-22
• Public Version Status: Update
• Public Device Record Key: b74c6f96-c273-454f-ad07-5e94629a0df9

Device Description

The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The charts are controlled by an optional remote control or the control box of the NIDEK refractor*1. In contrast to a chart presenting device which projects the charts from film, the SC-1600 displays the digitally stored chart shapes on the LCD. This makes the following possible.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100653	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]