Skip to content

Model 35300 Tracker Therapy Beam Evaluator

by Keithley Instruments, Inc.

510(k) K874893

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 NumberK874893 Date17 Feb 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Model 35300 Tracker(Tm) Therapy Beam Evaluator
510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Model 35300 Tracker Therapy Beam Evaluator is a medical device used in radiology. It is classified as a Class II medical device and is substantially equivalent to other devices. The device is used to evaluate therapy beams in medical settings.

The Model 35300 Tracker Therapy Beam Evaluator is supplied by Keithley Instruments, Inc. and has been cleared under FDA 510(k) number K874893. The device is intended for use in radiology and is regulated under product code IYE and regulation number 892.5050. It is a single device with a specific model number and is not described as single-use or reusable in the provided data.

Other devices from Keithley Instruments, Inc.