(7 days)
Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment parts, and accessories.
Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV
The Virgo system design comprises a gantry supporting a fixed 90 degree dual head detector and a patient chair. The Virgo system is operated through interaction with a graphical user interface situated on the acquisition PC and a dedicated Virgo hand controller.
The provided text describes acceptance criteria and reported device performance for the Virgo Gamma Camera System. The study conducted to prove the device meets these criteria is a non-clinical test following documented verification plans, often adhering to the NEMA Standard NU 1-1994.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Test Result) |
|---|---|
| Intrinsic Spatial Resolution, FWHM, UFOV: $\leq \pm 3.7mm$ | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m: $ 180k$ cps with scatter, $> 290k$ cps w/o scatter | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Count rate @ 20 % loss: $> 225k$ cps | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Detector Background Sensitivity, @180 °, 140 keV: $ |
§ 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.