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510(k) Data Aggregation
K Number
K161674Device Name
QuantumCam
Manufacturer
Date Cleared
2016-10-20
(126 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
DDD-DIAGNOSTIC A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multislice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, TI-201, I-123, I-131, In-111, Ga-67, Co-57.
Device Description
The QuantumCam is a general purpose dual detector gamma camera system comprised of a mechanical gantry allowing the Detectors to be positioned and moved in close proximity to the patient for scanning. The Gantry provides for positioning of the detectors in location(s) suitable for patient to be brought in position for tomographic, whole body scanning as well as planar scanning in sitting or standing position.
The Detectors are standard Nal (Sodium Iodide) / Photomultiplier based scintillation detectors designed following the Anger Camera principles first described by Hal Oscar Anger. This detector technology has been used effectively in Nuclear Medicine for decades. The Detectors are equipped with standard Collimators following the principles known to the industry and this submission is specific about the HEGP collimator. The image data from the detectors are collected by hardware in the detector and the data acquisition is controlled by software running on a standard personal computer with a suitable operating system. The data may subsequently be transferred to a Nuclear Medicine Workstation for processing and interpretation. This Workstation is not part of the QuantumCam system.
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K Number
K140206Device Name
SCINTILLATION GAMMA CAMERA
Manufacturer
Date Cleared
2014-05-08
(101 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
DDD-DIAGNOSTIC A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the QuantumCam gamma camera system is to perform general nuclear medicine imaging procedures. This is intended to be accomplished by imaging the distribution of a radiopharmaceutical within the human body. Gamma rays emitted from the radiopharmaceutical are detected by the gamma camera system and formed into images characterizing and showing the state of organs or structures in the form of functional images. When QuantumCam is connected to a nuclear medicine workstation, these images can be used in concert with other clinical data to assist in making clinical diagnoses by authorized medical personnel.
Indications for use.
The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, TI-201, I-123, In-111, Ga-67, Co-57.
Device Description
The QuantumCam is a general purpose dual detector gamma camera system comprised of a mechanical gantry allowing the Detectors to be positioned and moved in close proximity to the patient for scanning. The Gantry provides for positioning of the detectors in location(s) suitable for patient to be brought in position for tomographic, whole body scanning as well as planar scanning in sitting or standing position.
Functional description:
The Detectors are standard Nal (Sodium lodide) / Photomultiplier based scintillation detectors designed following the Anger Camera principles first described by Hal Oscar Anger. This detector technology has been used effectively in Nuclear Medicine for decades. The Detectors are equipped with standard Collimators following the principles known to the industry. The image data from the detectors are collected by hardware in the detector and the data acquisition is controlled by software running on a standard personal computer with a suitable operating system. The data may subsequently be transferred to a Nuclear Medicine Workstation for processing and interpretation. This Workstation is not part of the QuantumCam system.
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