Unidos Universal Dosimeter Model 10002-With Tnc Connector, 10005-With Bnt Connector

• • Terminated Z-2439-2015 FDA Class II ·initiated 27 May 2015

  In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.

510(k) Number

K951764 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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