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K Number
K101039
Device Name
SHIMADZU COLLIMATOR R-300
Manufacturer
SHIMADZU CORP.
Date Cleared
2010-09-20

(159 days)

Product Code
IZW
Regulation Number
892.1610
Type
Abbreviated
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Corporation regarding their R-300 device, a diagnostic x-ray beam-limiting device (collimator).

This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, it's a letter stating that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this document does not contain that level of detail. The information presented is focused on regulatory approval based on substantial equivalence to existing devices, not on de novo performance testing against specific acceptance criteria.

§ 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.