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This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

This is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR b) HF100H+ cleared in K052721 OR C) HF1202 PowerPlus cleared in K153059. d) Plus: A 510(k) cleared (K153058) Digital X-Ray Receptor Panel CareView 1500C X-ray Flat Panel Detector. PLUS: the dicomPACS® software package (Same as our predicate). e) The x-ray generators are portable units which operate from 120/240V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Careray flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate devices is the model number of the digital x-ray receptor panel. The predicate panel can communicate either by wireless or wired connection. The subject device communicates by Ethernet only.

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR b) HF100H+ cleared in K052721 OR c) HF1202 PowerPlus cleared in K153059. Plus: A 510(k) cleared (K150929) Digital X-Ray Receptor Panel CareView 1500Cw X-ray Flat Panel Detector. d) e) PLUS: the dicomPACS® software package (Same as our predicate). The x-ray generators are portable units which operate from 120/240V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Careray flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate devices is the supplier of the digital x-ray receptor panel.

The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.

Intended for use by a qualified trained physician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the digital x-ray receptor panel.

This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257.

This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.

This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Varian Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a porable unit thich operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency invester and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Varian flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture founovide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.

This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

This represents the straightforward interconnection of two FDA cleared devices: The MinXray HF120/60H PowerPlus™ (K040046) and the Canon CXDI-50G Solid State Imager (K031447). MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features Canon's large-area flat panel technology in a sleek and compact unit. The portable CXDI-50G provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.