(126 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the QuantumCam 9SYS2070-B02, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on NEMA (National Electrical Manufacturers Association) tests for gamma camera systems. The performance reported is for the new High Energy General Purpose (HEGP) collimator, which is the main addition that expands the device's energy range.
| Feature / Performance Metric | Acceptance Criteria (Specification) | Reported Device Performance (NEMA Test Result) |
|---|---|---|
| HEGP Collimator Hole Properties: | ||
| Shape | HEX | HEX (Measured and compared to Unicorn drawings) |
| Size | 3.0 mm | 3.0 mm (Measured and compared to Unicorn drawings) |
| Septa | 1.75 mm | 1.75 mm (Measured and compared to Unicorn drawings) |
| Length | 43 mm | 43 mm (Measured and compared to Unicorn drawings) |
| Device Performance with HEGP Collimator (NEMA Tests): | ||
| Sensitivity | 183 cpm/uCi | Not explicitly stated as a pass/fail. The value 183 cpm/uCi is given but not compared against a specific pass/fail threshold. |
| Spatial Resolution @ 10cm, HEGP Collimator |
§ 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.