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510(k) Data Aggregation
(298 days)
DRX-Evolution Plus X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.
DRX-Compass X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body,including the skull, spinal column, extremities, chest, abdomen, and other body parts. The device is not indicated for use in mammography.
Lux HD Detectors
Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general–purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.
Lux HD Digital Flat Panel Detectors (35x43, 43x43 sizes)
Lux HD 35x43 and 43x43 detectors are high-definition detectors (100um) designed with a Cesium Iodide (CsI) scintillator for the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by a diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics to form an image by transmitting to the device PC through the user interface. The CsI scintillator provides a high spatial resolution image which helps to increase the diagnostic confidence. The detectors use a glass free technology which makes the overall detector weight lighter and mitigates the risks related to device breakage. Lux HDs are designed with Digital Exposure Control (DEC) functionality which uses a wireless connection to communicate with a DEC control box, which in turn connects to the generator for x-ray control. This DEC feature also enables AEC functions to be used with out-of-bucky exams and mobile imaging without a physical wired connection.
Carestream In-Room X-ray Systems
The DRX Evolution Plus (K233381), DRX Compass (K223842) are permanently installed diagnostic x-ray systems for general radiographic x-ray imaging. These systems consist of a combination of components including an x-ray generator, workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). Currently, the DRX Evolution Plus X-ray system is designed to use a standalone automatic exposure control (AEC) chamber placed in front of the detector to control the x-ray exposures. Lux HD will be compatible with these systems. The DRX-Compass will not support the DEC feature; however the Lux HD detectors can still be used for general radiography.
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