(10 days)
The AXT 150M and/or its variations is intended to be used by or under the authority of a licensed MD or RT. The AXT 150M and/or its variations is accessories to control the x-ray beam for use on a diagnostic Imaging equipment. The intended market will consist of Original Equipment Manufacturers (OEM), as designed to be adapted to various x-ray systems.
AXT 150M Manual Collimator
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (AXT 150M Manual Collimator), indicating that the device is substantially equivalent to a predicate device.
The letter and the "Indications For Use" statement do not include:
- A table of acceptance criteria and reported device performance.
- Details about a study or clinical trial.
- Sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot fulfill the request based on the provided input.
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.