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The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples:

Routine Examinations Colon examinations Examinations of the digestive tract Lung fluoroscopy Examinations of the gall bladder Thorax examinations Skeleton imaging Pediatric examinations Special Applications (might require special accessories and technique) Angiography Myelography Phlebography Arthrography Bronchography Tomography Sialography Hysterosalpingography

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Velara familiy, with digital spot film cameras from the Philips DI family, and with a Philips ViewForum workstation. The system comes with a 4-mode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Ultramark 400C) can also be added. inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy. The system supports system-wide application-oriented presets and can be equipped with options for better integration into the hospital IT environment (bidirectional RIS coupling), advanced X-ray control techniques (in-pulse control), dose awareness (dose calculation or measurement, automatic prefilter setting), image handling (automatic iamge transfer to integrated viewing workstation), and postprocessing (overview image reconstruction).

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) summary for the Philips EasyDiagnost Eleva, which primarily focuses on demonstrating substantial equivalence to a predicate device, system description, safety information, and indications for use. It does not include details on specific performance metrics, testing methodologies, or clinical study results for novel performance claims.

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