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K Number
K960192
Device Name
POSITRON COINCIDENCE DETECTION
Manufacturer
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
Date Cleared
1996-09-12

(240 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 PCD Option to the Prism Dual Head system is a modification of a gamma camera system. 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.

Device Description

The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device includes adding hardware and software to a gamma camera system.

AI/ML Overview

The provided text is a 510(k) notice for the PCD Option to the Prism Dual Head System. It describes the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics that would allow me to populate the requested table and answer the detailed questions about the study proving the device meets those criteria.

The document states:

  • "Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera."
  • "The product will perform in accordance with the development specifications."
  • "A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."

These are general statements, not quantifiable acceptance criteria or detailed study results. Therefore, I cannot extract the specific information requested in your prompt based solely on the provided text.

To answer your questions, I would need a section of the document that outlines:

  • Specific, measurable acceptance criteria (e.g., "sensitivity > X%", "spatial resolution

§ 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.