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The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician 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. - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use. 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 Mobile X-ray System (Model: iQFlex Pro) consists of a LED display with up and down soft-keys for controlling kVp, an X-ray generator, an X-ray tube assembly, and a collimator. In addition, this unit has preset memory keys to store and select kVp/mAs. The iQFlex Pro can be used with a flat panel detector of choice. The subject device iQFlex Pro is not being provided with digital detectors. This device is a battery-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, main/sub console board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the main console board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the main console board. The user can adjust and control the kVp and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the inverter, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in medical facilities with mobile or fixed sites. The iQFlex Pro is not intended for mammography. Detectors are recommended but not provided with the iQFlex system. Detectors chosen must have been cleared by FDA have reasonable MTF and DQE values. The iQFlex Pro is not a cybersecurity device, however it has firmware and a USB-C port. The USB-C port is for battery charging only. The iQFlex Pro generator doesn't connect to the Internet, to other medical devices, and the supporting software doesn't offer a protocol for transfer of medical data.

The iQFlex M/iQFlex MD Mobile X-ray System is a medical device 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.

This Mobile X-ray System (Model: i9Flex M/iºFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (linepowered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iºFlex MD. In addition, this unit has preset memory keys to store and select kV/mAs, The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. The image detectors (a necessary component of a fully-functional diagnostic system) are not part of this submission. This device is a mains-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the system control board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the highvoltage tank to generate high-voltage to excite the X-ray tube inside to emit Xrays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. The iQFlex M/iºFlex MD is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This mobile X-ray system is designed for handheld or stand-mounted imaging. Model i®Flex MD can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device. The cybersecurity risks of the i9Flex M/iºFlex MD have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).