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The Legend CRF Fluoro and Rad System is designed to perform general purpose radiographic and fluoroscopic x-ray examinations. This device is not intended for mammographic applications.

The Legend CRF Fluoro and Rad System is indicated for use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedures. This device is not intended for mammographic applications.

The Legend CRF Fluoro and Rad System consists of an X-ray generator, angulating table with X-ray tube and collimator, image intensifier and spot film device. Optionally, the following items may also be part of the system:
-The table may be provided with an undertable bucky for use with an X-ray tube mounted on a ceiling mounted X-ray tube hanger.
-A basic radiographic table for use with an X-ray tube mounted on a ceiling mounted X-ray tube hanger may be included with the system.
-A separate, vertical bucky stand may also be provided for chest or other general purpose radiographic procedures.

The Legend CRF Fluoro and Rad System consists of an X-ray generator, angulating table with X-ray tube and collimator, image intensifier and spot film device. Optionally, the following items may also be part of the system:

• The table may be provided with an undertable bucky for use with an X-ray tube . mounted on a ceiling mounted X-ray tube hanger.
• . A basic radiographic table for use with an X-ray tube mounted on a ceiling mounted Xray tube hanger may be included with the system.
• A separate, vertical bucky stand mav also be provided for chest or other general . purpose radiographic procedures.

This document is a 510(k) premarket notification for the "Legend CRF Fluoro and Rad System" submitted by GE Medical Systems. It addresses the substantial equivalence of this device to previously marketed devices. However, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on:

• Device Description: What the system is composed of.
• Indications for Use: What the system is intended for.
• Conformance to Standards: Which regulatory and voluntary standards the device will conform to.
• Claim of Equivalence: That the device is equivalent to other marketed devices with the same indications for use and meeting similar standards.
• FDA Clearance Letter: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided text. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed performance study report.

To provide the requested information, a document describing a performance study, including acceptance criteria, methodology, results, and analysis, would be necessary.

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