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Solid State X-ray Imager (Flat Panel/Digital Imager) Indicated for use in generating radiographic images of human anatomy. Intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications.

The PZMEDICAL devices are used in medical x-ray imaging systems. The product can only be used by trained personnel of medical facilities. The product is only used for diagnostic x-ray image acquisition applications. The flat panel detector consists of a Csl scintillator screen and thin-film transistors. The scintillator screen converts the x-rays into visible light. Thin-film transistors convert the visible light to an electrical charge. The flat panel detector can then obtain a digital image by analog to digital conversion and associated circuits. These panels can be used to acquire diagnostic x-ray images as an upgrade to traditional film systems. They can be used wired (Ethernet) or wirelessly (Wi-Fi) and are powered either by AC Line or by rechargeable batteries. The various models are constructed similarly to our previous models cleared in K170480. The suffix "ZF" means FINE pixel size, 99 µm Z means standard pixel size, 139 µm. All models have a battery life indicator. The supporting software PZDR is functionally the same as provided with the predicate. The software performs acquisition of the RAW image and converts it to DICOM format and performs operations as described in the comparison table below. It is functionally unchanged from the predicate software.