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K Number
K992335
Device Name
BEACON-P, MODEL 211059
Manufacturer
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
Date Cleared
1999-10-07

(86 days)

Product Code
KPS
Regulation Number
892.1200
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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

AI/ML Overview

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.

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.