Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CAUTION [Personal information leakage] - User shall take necessary and appropriate precautions and exercise the reasonable degree of care in safeguarding user ID and password assigned to each employee of User who use the Software and operates the computer on which the Software runs, to prevent unauthorized use or access by any third party. [There is a risk of personal information leakage.] - User shall take necessary and appropriate precautions and exercise the reasonable degree of care in safeguarding the database administrator password used in the Software to prevent unauthorized use or access by any third party. [There is a risk of personal information leakage.] - The data and/or database files obtained through the Software based on client-server configuration may be placed on network. User shall be responsible for access control of the files as well as the folders that record such files. [There is a risk of personal information leakage.] - User shall properly manage computers, devices and media that record data obtained through use of the Software and back up data to prevent theft or unauthorized use by any third party. [There is a risk of personal information leakage.] - User shall completely erase the data before discarding the storage device. [There is a risk of personal information leakage.]

  OTHER

• CAUTION: [Misdiagnosis] - If the Software is used on computer which is connected to the network, User shall have appropriate security to prevent leakage of information and infection by computer viruses. [There is a risk of personal information leakage. In addition, the data may be falsified, leading to misdiagnosis.] - Users should not rely solely on images made using this instrument in making decisions regarding diagnosis or other therapeutic procedures, but should rely on their own expertise and judgment. The pertaining doctors should take the responsibility for diagnoses. [There is a risk of misdiagnosis]

  OTHER

• NOTE: ▪ Users with access to the PC and software must protect and manage the ID and password of the PC and software to avoid third party risks. ▪ Users with database administrator access must protect and manage the administrator log in information to avoid third party risks. ▪ When using the software via PC connected to a network, users must take necessary precautions against computer viruses and information leakage. ▪When using the software via client-server structure, the data and database files will most likely be displayed in the network. Users will need to organize into folders and manage access levels for different users. ▪PCs and other devices containing data obtained from the software and back-up data must be managed by users to avoid loss and unauthorized use.

  OTHER

• CAUTION [Ensuring Security] - Apply the security update to the computer on which this software runs, make use of anti-virus software and take other countermeasures against computer virus properly. - Do not connect any USB storage device that is not checked with the anti-virus software to the USB port of the computer on which this software runs. - Set the ID and password of the user to the computer on which this software runs. - Set appropriate access restrictions for the shared folder on the computer on which this software operates and the shared folder for outputting data from the computer on which this software operates. -- - Enable the firewall to prevent access to unused ports.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

OPHTHALMIC DATA SYSTEM IMAGEnet 6

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04571130282711

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4560126260080UF

Reference / catalog number

IMAGEnet 6

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Measures the length and area of the region surrounded by a line or rectangle.
• the ratio of “Cup” and “Disc” (C/D ratio) on optic disc according to the range specified by mouse operation.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12120192OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.