SKR 3000

The SKR 3000 is a digital radiography system that generates radiographic images of human anatomy using an X-ray planar detector, replacing traditional radiographic film/screen systems. It is intended for general-purpose diagnostic procedures and can be used for pediatric imaging, but is not indicated for mammography, fluoroscopy, or angiography.

The subject device has identical technological characteristics to the primary predicate device (K241319 SKR 3000). Both use an X-ray planar detector, Console CS-7 software with image processing features (gradation, frequency, dynamic range compression, smoothing, rotation, reversing, zooming, and Intelligent-Grid), and support wired Ethernet and wireless LAN (IEEE 802.11a/n) communication with WPA2-PSK (AES) encryption.

The submission cites the FDA 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' as the basis for image quality evaluation methodology.

The device is substantially equivalent because it has identical technological characteristics to the predicate and demonstrates substantially equivalent image performance. The only change is explicit addition of pediatric use indications for the P-53 detector, supported by comparative pediatric image evaluation using small-size phantoms showing the SKR 3000 with P-53 provides equivalent image performance to the AeroDR System 2 with P-52 for pediatric use, which does not alter the intended use or safety/effectiveness profile.