SKR 3000
Konica Minolta, Inc.The SKR 3000 is a digital X-ray imaging system designed to replace traditional film/screen radiography in general diagnostic radiographic procedures. It uses an advanced flat-panel detector with antibacterial properties and wireless communication capabilities to capture detailed digital images of the human body, helping clinicians efficiently obtain and manage diagnostic images. This system is intended for adult use and excludes applications like mammography, fluoroscopy, and angiography.
Intended Use
The SKR 3000 is indicated for use in generating radiographic images of human anatomy, intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. Not indicated for mammography, fluoroscopy, or angiography. The P-53 detector is for adult use only.
Technology
The SKR 3000 uses a flat-panel digital X-ray detector (P-53) employing an indirect conversion method with Cesium Iodide scintillator and glass-based TFT substrate. It outputs digital signals processed by software (CS-7) which applies gradation, frequency, dynamic range compression, smoothing, rotation, zooming, and grid removal with scattered radiation correction (Intelligent-Grid). The detector supports wired Ethernet and wireless LAN communication with security encryption. The new P-53 panel shows improved resolution and detective quantum efficiency compared to predicate devices.
Performance
Performance testing included electrical safety, electromagnetic compatibility testing, software verification and validation, cybersecurity testing, and image performance comparison to predicate devices. Testing demonstrated the SKR 3000 meets acceptance criteria with improved image performance over predicate devices. No clinical studies were required as per risk analysis.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2024
6 months - 2
FDA Approval
11/21/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.