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Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). This device is not intended for mammography and pediatric patients.

This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below. | Model | ManntiX B | ManntiX K | |---------------------------------------------------------|------------------|-----------| | Portable X-ray Assembly (including collimator and tube) | PX10 | PX10 Pro | | X-ray Protective Device (optional) | BA-01 | | | Mobile Stand | MS-05P | MS-10P | | Digital Detector (optional) | CareView 1500Cwe | | | | Mars1717X | | | | Luna 1012X | | | Image Processing System (optional) | MOC (V03) | | | Image Acquisition Workstation (optional) | BWS-10 | | Note: - 1. ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them. - 2. A computer system, necessary for image viewing and manipulation, is not part of the device. The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation. Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.

Intended for use by a qualified/trained doctor or technician on adult 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.

The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.