(134 days)
This device is intended to be used in radiology.
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 for diagnostic use.
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.
The provided document is an FDA 510(k) clearance letter for the R-201 device, which is a diagnostic x-ray beam-limiting device (collimator).
Unfortunately, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.
The letter primarily provides:
- Confirmation of substantial equivalence to predicate devices.
- The device's regulation number, name, and product code.
- Indications for use.
- General regulatory information and requirements for marketing the device.
It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert qualifications, adjudication methods, or MRMC studies.
- Data on standalone algorithm performance.
- Training set details.
To answer these questions, one would need to review the original 510(k) submission (K101036) document, which would contain the performance data and testing methodology used to demonstrate substantial equivalence. The provided FDA letter is merely the agency's response to that submission.
§ 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.