(230 days)
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) fluoroscopy system aims to provide imaging performance comparable to existing fluoroscopy systems by incorporating a solid-state flat-panel detector (FPD).
1. A table of acceptance criteria and the reported device performance:
The document provides detailed technical specifications for the CS-series-FP (SSXI) system, which serve as its performance criteria. The device is reported to meet these specifications directly by listing them as characteristics of the system.
| Acceptance Criteria (Technical Specifications of CS-series-FP) | Reported Device Performance |
|---|---|
| 1. Flat Panel Detector | |
| 1.1 Receptor Type: Amorphous Silicon | Amorphous Silicon |
| 1.2 Conversion Screen: Cesium Iodide | Cesium Iodide |
| 1.3 Pixel Area - Active: 19.8 cm X 19.8 cm | 19.8 cm X 19.8 cm |
| 1.4 Pixel Matrix - Active: 1024 X 1024 | 1024 X 1024 |
| 1.5 Pixel Pitch: 194 $\mu$m | 194 $\mu$m |
| 1.6 Limiting Resolution: 2.58 lp/mm | 2.58 lp/mm |
| 1.7 MTF, X-ray: $\geq$ 35% @ 1.30 lp/mm | $\geq$ 35% @ 1.30 lp/mm |
| 1.8 Energy Range: 40 - 150 kV | 40 - 150 kV |
| 1.9 Fill Factor: 70% | 70% |
| 1.10 Dynamic Range: 72 dB | 72 dB |
| 1.11 Contrast Ratio: Large Area (120mm): |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.