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510(k) Data Aggregation
(12 days)
C.CAM-AC
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera.
C.cam gamma camera is a dual detector system and the attenuation correction device (two units) will be mounted opposite of the two detectors, one device on each detector. The attenuation correction device is formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control.
The following described functions are performed on both detectors simultaneously.
When the scanning is initiated the emission image and the transmission images are acquired sequentially. When the emission image has been acquired, a shutter, common for all sources, located in the device housing will open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total of max. 96 mCi). A collimated beam of gamma ray photons is focused on the opposite detector field of view to create the transmission images of the patient placed in the field of view of the detector. Having acquired both emission and transmission images, the data for emission, transmission, emission scatter and transmission scatter are stored in one dataset. A scaled version of the blank transmission scan is stored in another dataset. The complete study can be export via DICOM to the OEM customer provided processing station for later processing and reviewing.
Here's a breakdown of the acceptance criteria and study information for the c.cam-AC device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K051460 describes a device that is essentially equivalent to existing devices and focuses on its design and radioactive source rather than specific performance metrics tied to acceptance criteria. The only performance-related data explicitly stated are for Radiation Leakage.
| Acceptance Criteria (What the device aims to achieve) | Reported Device Performance |
|---|---|
| Radiation Leakage: | |
| Exposure from surface of housing, shutter closed |
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(7 days)
C.CAM
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: $ |
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