(28 days)
As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
The pixium 4343RCE is a Stationary x-ray system that converts x-ray patterns into electrical signals. The signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.
The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered by and connected with the x-ray system. The device is connected to the Philips Eleva Workspot to create a complete x-ray imaging chain, and it is intended to be used in Philips x-ray systems such as the DigitalDiagnost.
The provided text describes the Philips pixium 4343RCE, a stationary x-ray system. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device (Philips pixium 4343RC, K131483).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific numerical acceptance criteria (e.g., minimum DQE, MTF values that must be met) for the pixium 4343RCE, nor does it provide a direct side-by-side comparison of claimed performance data against such defined criteria. Instead, the acceptance criteria are implicitly stated as demonstrating similar performance to the predicate device and compliance with various standards. The "Discussion" column in the comparison table serves as the "reported device performance" against the implicitly accepted criterion of not negatively impacting safety or effectiveness compared to the predicate.
Here's a table summarizing relevant performance metrics and the discussion provided, which indicates how the device meets (or is considered to meet) implied acceptance criteria of non-inferiority or slight improvement:
| Feature | Predicate Device pixium 4343RC (K131483) | Proposed Device pixium 4343RCE (K170113) | Discussion / Performance vs. Implied Acceptance Criteria |
|---|---|---|---|
| Design Features | |||
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Identical; no impact to safety and effectiveness. |
| Installation type | Stationary, permanently installed | Stationary, permanently installed | Identical; no impact to safety and effectiveness. |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Identical; no impact to safety and effectiveness. |
| Detector Size | 500 x 490 x 45.5 mm³ | 500 x 490 x 45 mm³ | Similar, slightly smaller; no impact to safety or effectiveness. |
| Detector Weight |
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.