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The Optima XR120 is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating images on film or digitally. This device is not intended for mammographic applications.

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The provided text does not describe acceptance criteria and a study that proves the device meets the acceptance criteria. Instead, it is a 510(k) Premarket Notification Summary for the GE Healthcare Optima™ XR120.

Here's what the document states:

• No clinical studies were required to support substantial equivalence. The document explicitly says: "The subject of this premarket submission, Optima XR120, did not require clinical studies to support substantial equivalence."
• Substantial equivalence was determined based on fundamental scientific technology and quality assurance measures. The document mentions: "The GE Healthcare Optima™ XR120 employs the same fundamental scientific technology as its predicate devices." and lists quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, performance, safety, simulated use).

Therefore, I cannot provide the requested information, as the included document indicates that a study proving the device meets acceptance criteria (in the context of clinical performance) was not part of this specific submission.

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