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The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations. It may also be used in: lymphography, endoscopy, myelography, venography and arthrography. The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed). The Platinum dRF is not indicated for use in interventional radiology.

The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales. The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection. The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis. The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System. The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures. The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS Group manufactured radiological examination table, control panel with system controller software, and electrical panel. The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography.

The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA). The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. The Platinum dRF is not indicated for use in interventional radiology.

The Apelem-DMS Platinum dRF Imaging System ("Platinum") is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software, and electrical panel. The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media. The subject of this Special 510(k) application is the additional offering of the Platinum with a different flat panel detector (RF4343 FL) that does not include some less regularly used options (of the FDA cleared Platinum with RF4343 flat panel detector), has lower frames/sec and does not include a lead shield for use with the RF4343 FL is manufactured and installed by DMS. This additional offering is less expensive and will fit the needs of most customers.

The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA). The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. The Platinum dRF is not indicated for use in interventional radiology.

The Apelem-DMS Platinum dRF Imaging System (Platinum) is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator. X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software. and electrical panel. The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media.