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This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are: a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient. b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation. c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°). d) Controls for lock release of Rotating Column and Telescopic Arm. e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm. f) X-ray Handswitch for X-ray exposures and Collimator Light. Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g) h) Dosimetry (optional): i) DAP reading with an Ion Chamber. i) ii) Calculated DAP (eDAP). i) Manual Collimation. Tube protection circuitry prolongs Tube life and increases system performance. i) Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments. There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.

This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a capacitor assisted mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with a battery to supply the internal PC up to 3 hours without mains connection. This system has been made lighter and more maneuverable, such that battery assisted motorized movement is no longer necessary. The removal of the movement motorization and the required rechargeable batteries resulted in a much lighter system. The generator is also smaller resulting in further weight reduction. The indication for use remains the same as the predicate. The system uses a different xray generator than the one used by the predicate but both are monoblock x-ray generators (same type of generator). The collimator has been changed from the Ralco R108F to the Varex Optica 10. They are functionally identical, having just two manual controls. Although the available generator options have lower peak outputs, the full range of examinations can still be made.

This is a digital mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a modified version of our previous predicate mobile PHOENIX. The predicate PHOENIX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. PHOENIX mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR TX m01. Models with the Ultra software will be marketed as mKDR Xpress. The modification adds two new models of compatible Konica-Minolta digital panels, the AeroDR P-65 and AeroDR P-75, cleared in K210619. These newly compatible models are capable of a mode called DDR, Dynamic Digital Radiography wherein a series of radiographic exposures can be rapidly acquired, up to 15 frames per seconds maximum (300 frames).

This is a digital mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a new type of our previous predicate mobile PhoeniX. The predicate PhoeniX mobile is interfaced with Canon Digital X-ray panels and Canon control software CXDI-NE. The new PhoeniX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. Phoenix mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR Tran-X Models with the Ultra Software will be marketed as mKDR II. The compatible digital receptor panels are the same for either model. The CS-7 software was cleared under K151465/K172793, while the Ultra software is new. The CS-7 is a DIRECT DIGITIZER used with an image diagnosis device, medical imaging device and image storage device connected via the network. This device digitally processes patient images collected by the medical imaging device to provide image and patient information. By contrast the Ultra-DR software is designed as an exam-based modality image acquisition tool. Ultra-DR software and its accompanying Universal Acquisition Interface (UAI) were developed to be acquisition device independent. Basic Features of the software include Modality Worklist Management (MWM) / Modality Worklist (MWL) support, DICOM Send, CD Burn, DICOM Print, and Exam Procedure Mapping. Ultra Software is designed to increase patient throughput while minimizing data input errors. Ultra is made up of multiple components that increase efficiency while minimizing errors. The main components of Ultra are the Worklist, Acquisition Interface and Configuration Utility. These components combine to create a Stable, Powerful, and Customizable Image capture system. The intuitive graphical user interface is designed to improve Radiology, Technologist accuracy, and image quality. Worklist and Exam screens were developed to allow site specific customizations to seamlessly integrate into existing practice workflows.

These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices. It is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult. Radiographic System Proteus XR/f has been interfaced with the Digital Imaging System of Konica Minolta Inc consisting of the image receptor and application for image acquisition (control console & image processing controller).

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremittes, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography.

The MobileDiagnost wDR 2.2 is a motorized mobile radiographic system consisting of a mobile base unit, a user interface consisting of Eleva Workspot combined with flat solid state X-ray detectors used to operate, generate, process and handle digital X- ray images. The MobileDiagnost wDR 2.2 integrates a new wireless portable detector (SkyPlate E). The family of SkyPlate detectors (Large and Small) have already been integrated into the MobileDiagnost wDR 2.0 based on the K141736 pre-market submission.

These Portable Diagnostic Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).

DRAGON X SPSL4HC and DRAGON X SPSL8HC are mobile x-ray units that cover all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These line operated units combine stand-alone feature for exposures for ease in imaging. Two different models of digital image acquisition panels are offered: FDX3543RP and FDX3543RPW. Both of the Toshiba panels and the associated software have been previously cleared by FDA (K130883). Integration with the portable system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed.

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography.

The MobileDiagnost wDR 2.0 system is a motorized mobile radiographic system consisting of a mobile base unit, and a user interface (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images. The MobileDiagnost wDR 2.0 integrates a new generation of wireless portable x-ray detectors (SkyPlate) to replace the former detector WPD FD-W17 cleared under the predicate submission (K111725).

Sedecal "NOVA FA DR System" is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized