(14 days)
The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel.
The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs. The device is not interpretative. Data from the device are interpreted by medical personnel who, based on these, make the clinical diagnosis.
The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.
Here's a summary of the acceptance criteria and study information for the CapIMAGE Gamma Camera System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CapIMAGE device are based on compliance with industry standards, specifically NEMA NU 1-2001 for performance specifications. The reported device performance metrics are presented as meeting or being within the specified limits of these standards. The document doesn't provide specific quantitative acceptance thresholds for each performance characteristic but implies compliance.
| Performance Characteristic | Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|---|
| Energy range | NEMA NU 1-2001 compliant | 59kev – 167kev |
| Detector UFOV | NEMA NU 1-2001 compliant | Ø 210 mm (8.3") |
| Intrinsic Spatial Res. | NEMA NU 1-2001 compliant | ≤ ± 3.7mm @ UFOV / FWHM |
| Energy Resolution | NEMA NU 1-2001 compliant | ≤ 9.4% @ Tc-99m |
| Spatial Linearity | NEMA NU 1-2001 compliant | ≤ ± 0.5mm @ UFOV |
| Flood Field Uniformity | NEMA NU 1-2001 compliant | ≤ ± 2.7% @ UFOV Intrinsic |
| Intrinsic Uniformity, UFOV, Differential | NEMA NU 1-2001 compliant | 180k cps @ 20% loss |
| Spatial Resolution, FWHM, LEGP Tc-99m. | NEMA NU 1-2001 compliant |
§ 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).