Search Results

The Beacon P system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device.
The Beacon P option is intended to be used specifically for Attenuation Correction of Coincidence Imaging of position emitters performed only on Axis or Irix gamma camera systems.

This device includes adding hardware and software to a gamma camera system.

The provided text for K992335 is a 510(k) summary for the Beacon P system, a new option for non-uniform attenuation correction on Axis or Irix gamma camera systems. While it states the device is "substantially equivalent to legally marketed devices" and will "perform in accordance with the development specifications," it does not include detailed acceptance criteria or a specific study proving the device meets those criteria.

The 510(k) summary mentions:

• "Laboratory tests will be run to validate the image quality performance of the system."
• "The product will perform in accordance with the development specifications."
• "A matrix was enclosed comparing the Beacon P to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."

However, none of the specific details requested in your prompt (like acceptance criteria values, reported performance metrics, sample sizes, ground truth establishment, expert qualifications, or study types like MRMC or standalone) are present in the provided document sections.

Therefore, I cannot populate the table or answer the specific questions about the study from this text. The text only provides a general statement of intent and a comparison to a predicate device for substantial equivalence, not a detailed performance study report.

Ask a specific question about this device