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K Number
K993813
Device Name
LUMAGEM SCINTILLATION CAMERA
Manufacturer
GAMMA MEDICA
Date Cleared
2000-01-18

(69 days)

Product Code
IYX
Regulation Number
892.1100
Type
Traditional
Panel
RA
Reference & Predicate Devices
K921296,K961104,K885054
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.

Device Description

The principles of operation and technology incorporated in the LumaGEM™ are equivalent to scintillation gamma cameras which use a combination of a scintillator with photomultiplier tubes as a photon radiation detector. The LumaGEM™ gamma camera includes signal analysis and display equipment, equipment supports and accessories.

AI/ML Overview

The provided text describes a 510(k) summary for the "LumaGEM™ Scintillation Camera" but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

  • Identifying the device and its manufacturer.
  • Stating its intended use (measuring and imaging the distribution of radionuclides in the human body).
  • Claiming substantial equivalence to predicate devices (ADAC S315, Elscint APEX SPX-4, DIGIRAD Notebook Imager, Siemens Orbiter, and SCINTICOR System Seventy Five).
  • Highlighting the main difference: the LumaGEM™ camera uses position-sensitive photomultiplier tubes, which are stated to improve spatial resolution and potentially decrease risk due to reduced detector weight.
  • Indicating the energy range for planar imaging (30-300 keV).
  • A letter from the FDA confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the given text. The document is a regulatory submission for premarket notification, not a detailed technical report or clinical study outlining performance metrics against acceptance criteria.

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).