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Canon Full Auto Tonometer TX-F

by Canon, Inc.-Utsunomiya Optical Products Operation

510(k) K023816

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023816 Date26 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HKX
Device Class
Class II
Regulation
21 CFR Part 886.1930
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Canon Full Auto Tonometer TX-F is a tonometer, ac-powered device used for measuring intraocular pressure without contact with the examinee's eye. It employs a three-dimensional tracking system to automatically perform alignment and measurement after the user displays the examinee's eye on the monitor and activates the switch.

This device is supplied as a measuring instrument for ophthalmic use and is authorized under FDA 510(k) clearance K023816. It is intended for use in clinical settings where non-contact tonometry is performed, and its regulatory classification falls under device class 2 with product code HKX and regulation number 886.1930.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Canon Full Auto Tonometer TX-F used for?

    The Canon Full Auto Tonometer TX-F is used for measuring intraocular pressure without contact with the eye, employing a three-dimensional tracking system to automatically align and measure after the user positions the eye on the monitor and activates the switch.

  • How is the Canon Full Auto Tonometer TX-F powered and operated?

    The device is ac-powered and operates automatically once the user displays the examinee's eye on the monitor and activates the switch, triggering the three-dimensional tracking system to perform alignment and measurement without manual adjustment.

  • Is the Canon Full Auto Tonometer TX-F supplied as a sterile or single-use device?

    The device is supplied as a measuring instrument for ophthalmic use and is not described as sterile or single-use in the provided data; it is a reusable ac-powered tonometer intended for clinical settings where non-contact tonometry is performed.