Search Results

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is intended to be used in the radiology.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a Beam Limiting Device R-20J. It does not contain information about acceptance criteria or a study proving that the device meets such criteria because it pertains to a traditional medical device (a collimator), not an AI/ML-driven device.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "device performance," "sample size," "ground truth," "MRMC study," or "standalone performance" as they relate to AI/ML device testing are not applicable to this document.

Ask a specific question about this device