MXD100/Mx 20, or Mx 30, or Mx 40 or Mx 50--(Mxd 100 Series)
510(k) K011111
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011111 | Date30 May 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MXD100 Series (MX 20, MX 30, MX 40, MX 50) is a Stationary X-Ray System, designed for fixed-position radiographic imaging. These devices generate high-quality X-ray images for diagnostic purposes in radiology, supporting a range of clinical evaluations including orthopedics, cardiology, and general radiography. Their modular design allows for adaptability to various clinical settings, ensuring versatility in imaging applications.
The MXD100 Series is intended for use in controlled clinical environments, such as hospitals or radiology clinics. These systems are non-sterile, reusable devices and are classified as Class II under FDA regulations. They are supplied as complete imaging systems, requiring proper installation and maintenance in accordance with manufacturer guidelines. The devices are authorized under FDA 510(k) clearance and comply with regulatory standards outlined in 21 CFR 892.1680 for stationary X-ray systems.
Questions
AI-generated answers, 1 Oct 2026
What clinical specialties is the MXD100 Series designed to support?
The MXD100 Series is specifically engineered for diagnostic radiographic imaging across radiology, with a focus on orthopedics, cardiology, and general radiography. Its high-quality imaging capabilities make it suitable for detailed evaluations in these specialties, ensuring accurate diagnostic results for clinicians.
How is the MXD100 Series supplied, and what does a complete system include?
The MXD100 Series is supplied as a complete stationary X-ray imaging system. This includes all necessary components for radiographic imaging, such as the X-ray generator, detector, and associated hardware. However, proper installation and maintenance must be carried out in accordance with the manufacturer’s guidelines to ensure optimal performance and safety.
Is the MXD100 Series sterile or reusable, and how does this affect its use?
The MXD100 Series is a non-sterile, reusable device. Since it is not sterile, it is intended for use in controlled clinical environments like hospitals or radiology clinics, where contamination risks are minimized through proper handling, maintenance, and cleaning protocols. Reusability extends the device’s lifespan while ensuring cost-effectiveness for healthcare facilities.
What models are available in the MXD100 Series, and how do they differ?
The MXD100 Series includes four models: MX 20, MX 30, MX 40, and MX 50. While the exact technical specifications differentiating each model are not detailed here, the modular design allows for adaptability to various clinical settings. Each model is intended to provide high-quality radiographic imaging tailored to different operational needs within radiology departments.
What regulatory approvals does the MXD100 Series hold, and how does this impact its use?
The MXD100 Series is authorized under FDA 510(k) clearance, classified as a Class II medical device. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. Compliance with 21 CFR 892.1680 further governs its use in stationary X-ray imaging applications.