Full Auto Tonometer Model TX-20

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Full Auto Tonometer TX-20 EUDAMED

Canon Inc. GUDID

Generic Name

Ophthalmic tonometer, line-powered

Device Name

Tx-20P

Model / Reference

Full Auto Tonometer EUDAMED

BT8-2590 EUDAMED

TX-20 GUDID

Primary DI / UDI-DI

04549292074369

Basic UDI-DI

4549292to01FV

510(k) Number

K111710 ↗

FDA Product Code

HKX

EMDN Code

Z12120122 Tonometers

GMDN Term

Ophthalmic tonometer, line-powered

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 886.1930

EU market of registration

Netherlands

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Digital Radiography

  Class II

  FDA 510(k) K112309 Active Cleared 2 Sep 2011

• Digital Retinal Camera

  Class II

  FDA 510(k) K102013 Active Cleared 29 Oct 2010

• Flat Panel Detector

  Class II

  FDA 510(k) K111824 Active Cleared 23 Apr 2012

• Ophthalmic Software Platform RX

  Class II

  FDA 510(k) K173689 Active Cleared 23 Feb 2018

• Mobile C-Arm

  Class II

  FDA 510(k) K121303 Active Cleared 26 Jul 2012

• CSX-30 Flat Panel Detector

  Class II

  FDA 510(k) K162909 Active Cleared 27 Jan 2017

See all devices from Canon Inc. -Medical Equipment Group →

• What clinical conditions is the Full Auto Tonometer Model TX-20 primarily used to monitor or diagnose?

  The Full Auto Tonometer Model TX-20 is designed to measure intraocular pressure (IOP), which aids in the diagnosis and ongoing monitoring of glaucoma and other ocular conditions that may involve elevated eye pressure. By delivering a controlled air puff to the cornea, it provides quantitative measurements to help clinicians assess and track these conditions over time.

• Is the Full Auto Tonometer Model TX-20 intended for single-use or reusable applications, and how should it be handled in a clinical setting?

  The Full Auto Tonometer Model TX-20 is explicitly supplied as a reusable medical instrument. It is intended for use in sterile or semi-sterile environments, such as ophthalmology offices or hospitals, and must adhere to standard ophthalmic safety protocols to ensure proper disinfection and maintenance between uses. This design supports single-user applications while maintaining clinical hygiene standards.

• What power source does the Full Auto Tonometer Model TX-20 require, and does it include any accessories for setup?

  The Full Auto Tonometer Model TX-20 operates on AC power, meaning it must be plugged into a standard electrical outlet for use. The device description does not specify included accessories, but typical air-puff tonometers like this would require minimal setup beyond power connection, such as calibration or cleaning supplies provided separately by the manufacturer.

• What regulatory pathways has the Full Auto Tonometer Model TX-20 followed, and how does this affect its use in clinical settings?

  The device has undergone FDA 510(k) clearance and complies with MDR (Medical Device Regulation) requirements, classifying it as a Class II medical device. This regulatory route ensures it meets stringent safety and performance standards for ophthalmic use, allowing clinicians to rely on its measurements for diagnostic and monitoring purposes in approved clinical settings like ophthalmology offices and hospitals.

• Are there multiple models or sizes available for the Full Auto Tonometer Model TX-20, or is this a single unified device?

  The provided data specifies only the Full Auto Tonometer Model TX-20 as the device name, with no mention of additional models or sizes. This suggests it is a single, unified product designed for general ophthalmic use, though specific variations (e.g., accessories or software updates) may exist outside the scope of the regulatory submission details.