SKR 3000
KONICA MINOLTA, INC.The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.
Intended Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
Technology
The SKR 3000 digital radiography system uses an X-ray planar detector outputting a digital signal processed by the Console CS-7 software. The software implements image processing such as gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal/scattered radiation correction (Intelligent-Grid). It communicates via wired Ethernet or wireless LAN with WPA2-PSK (AES) encryption.
Performance
Image quality evaluation using small-size phantoms was conducted to support pediatric use indications for the detector P-53, demonstrating substantially equivalent image performance compared to the AeroDR System 2 (predicate device) for pediatric use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/5/2025
3 months - 2
FDA Approval
6/17/2025
Other devices from KONICA MINOLTA, INC.
- SKR 30002024 • 510K
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