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Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

The Prudent 1717, Prudent 1417, Prudent 1212 are digital radiography systems, featuring an integrated flat panel digital detector (FPD). It is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features and rechargeable battery operation. The Prudent 1717 is available in 3 pixel sizes: 100/140/168 um whereas the Prudent 1417, Prudent 1212 are available in two pixel sizes: 100/140 µm. The available resolutions vary according to the comparison table below. All of the models are Wi-Fi wired) and rechargeable battery (or AC line) operated. The device employs the same software as cleared in the predicate with only minor changes made.

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic applications

The PIXX2430 is s digital radiography system, featuring an integrated flat panel digital detector (FPD). It is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panels (K182533, PIXX 1717, PIXX 1212) retaining the Wi-Fi wireless features and rechargeable battery operation. The scintillator is Csl only. The only size available is 12 x 10 inch. It operates either wirelessly or by hard wired Ethernet connection. The power source is rechargeable battery, which lasts for 360 images or 6 hours in standby. It has a finer than usual pixel pitch at 85 µm (finer resolution). Our imaging software is unchanged from our predicate device, K182533. Image storage functionality: PIXX2430 supports the internal storage of raw image data. Wireless Information: This digital panel employs the same wireless functionality as our predicate panels (K182533) using IEEE802.11ac, backward compatible. The operational characteristics can be summarized this way: Transfer power, ~ 100mW; Frequency: 2.4 gHz, or 5 gHz. Security, WPA2; Signal range: Approximately 100 feet. Both medical and nonmedical devices can use IEEE802.11ac Wi-Fi, and this technology is designed to handle multiple devices using the same technology simultaneously.

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features. The modification involves adding battery power capability to the devices in our previous submission K180976.

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features.