Identifiers
- 510(k) Number
- K162504 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SKR 3000 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for capturing high-resolution radiographic images in radiology settings. It functions as a digital detector, converting X-ray exposure into electronic signals for real-time imaging, replacing traditional film-based systems with a more efficient, wireless-capable alternative.
This device is intended for use in radiology departments, supplied as a reusable medical instrument with no indication of sterility requirements. It operates within Class II regulatory classification under FDA 510(k) clearance (K162504) and adheres to MRI safety standards as a non-MRI conditional device. Multiple model variants are listed under registration numbers, including 3009717300 and others, with no specified storage conditions beyond standard medical equipment protocols.
Frequently asked questions
What types of imaging procedures is the SKR 3000 designed to support in a radiology department?
The SKR 3000 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed to capture high-resolution radiographic images, replacing traditional film-based systems. It is intended for general radiology applications, including but not limited to X-ray imaging, where real-time digital imaging is required. Its wireless capability and digital detector functionality make it suitable for dynamic procedures like fluoroscopy, as well as static imaging tasks.
Is the SKR 3000 a single-use or reusable device, and what does that mean for maintenance?
The SKR 3000 is explicitly described as a reusable medical instrument, meaning it is not intended for single-use disposal. This implies that it must be cleaned, disinfected, and maintained according to standard medical equipment protocols to ensure proper functionality and infection control. Reusability also means it requires periodic calibration and servicing to maintain imaging accuracy.
Are there different sizes or models of the SKR 3000, and how do I identify the correct one for my facility?
Yes, the SKR 3000 comes in multiple model variants, each associated with a unique registration number (e.g., 3009717300, 3015223550, etc.). These variants may differ in technical specifications or form factors, such as detector size or connectivity options. To identify the correct model for your facility, consult your radiology department’s workflow requirements or contact Konica Minolta’s technical support, as the registration numbers correspond to specific configurations listed in regulatory filings.
Does the SKR 3000 require special storage conditions, and what should I consider when storing it?
The SKR 3000 does not specify unique storage conditions beyond those required for standard medical equipment. However, as a digital radiographic imager, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, or humidity. Ensure it is powered off and disconnected when not in use to prevent wear on components. Follow manufacturer guidelines for any additional precautions, such as avoiding exposure to magnetic fields or electrostatic discharge.
How does the SKR 3000 comply with MRI safety standards, and what limitations should clinicians be aware of?
The SKR 3000 is classified as a non-MRI conditional device, meaning it is not safe for use in the MRI environment under any circumstances. Clinicians should avoid placing it near MRI systems or using it in proximity to magnetic fields, as this could compromise its functionality or pose safety risks. Always verify its placement relative to MRI zones and adhere to facility-specific MRI safety protocols to prevent interference or damage.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Konica minolta SKR 3000 Manuals | ManualsLib, KONICA MINOLTA SKR 3000 : User's Manual - ManualShelf, PDF KONICA MINOLTA SKR3000 Direct Digitizer User Manual, PDF DIRECT DIGITIZER SKR 3000 Operation Manual - FCC ID Search
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162504 | Class II | Active |
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Manufacturer
- Manufacturer
- Konica Minolta, Inc.
Sources (1)
- FDA 510(k) K162504 24 fields · synced Sep 19, 2026