Diamentor Patient X-Ray Exposure Indicator 07302

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

510(k) Number

K853753 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Diamentor Patient X-Ray Exposure Indicator 07302 in a radiology setting?

  The Diamentor Patient X-Ray Exposure Indicator 07302 is designed to monitor and provide real-time feedback on patient radiation exposure during X-ray imaging procedures. This helps radiology staff maintain safe and controlled exposure levels, ensuring compliance with radiation safety protocols.

• Is the Diamentor Patient X-Ray Exposure Indicator 07302 intended for single-use or reusable applications?

  The regulatory data does not specify whether the device is single-use or reusable. However, it is described as a *stationary system*, meaning it is permanently installed for continuous monitoring in radiology settings, which implies it is not portable or disposable.

• How is the Diamentor Patient X-Ray Exposure Indicator 07302 regulated, and what was the decision outcome for its FDA submission?

  The device was submitted under the *Radiology* advisory committee (RA) and received *FDA 510(k) clearance* (K853753) in 1985. The decision was classified as *Substantially Equivalent (SESE)*, meaning it was determined to have the same technological characteristics as a legally marketed device.

• What types of facilities or departments would typically use the Diamentor Patient X-Ray Exposure Indicator 07302?

  The device is explicitly intended for use in *radiology settings*, where X-ray imaging procedures are conducted. Its purpose aligns with ensuring radiation safety in environments where patient exposure to X-rays is a routine concern.

• Are there different models or sizes available for the Diamentor Patient X-Ray Exposure Indicator 07302?

  The provided data does not specify distinct models or sizes for the Diamentor Patient X-Ray Exposure Indicator 07302. However, the device is listed under multiple *registration numbers* and *FEI numbers*, which may correspond to variations or different installations, but no explicit sizing or model differentiation is mentioned.