Xmc-S Tubestand Xmt-S Table Xmh-Ntwall
510(k) K842094
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842094 | Date24 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IXQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1980
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Radiographic, Stationary Top Table designed for use in radiology. It includes a tubestand (XMC-S), a tabletop (XMT-S), and a wall-mounted component (XMH-NT), collectively supporting radiographic imaging procedures. The components are engineered to position patients and equipment for optimal X-ray capture in stationary radiographic systems.
The XMC-S Tubestand, XMT-S Table, and XMH-NT Wall are supplied as a Class II radiographic system with Traditional 510(k) clearance (K842094) from the FDA. These components are intended for single-use or reusable settings, depending on facility protocols, and are not classified as MRI-safe. The system is regulated under FDA regulation number 892.1980 and is designed for use in radiology departments. Storage and maintenance follow standard radiographic equipment protocols.
Questions
AI-generated answers, 1 Oct 2026
What is the XMC-S Tubestand XMT-S Table Radiographic System designed for?
This system is designed specifically for radiographic imaging procedures in radiology departments. It combines a tubestand (XMC-S), a tabletop (XMT-S), and a wall-mounted component (XMH-NT) to position patients and equipment optimally for stationary X-ray capture. The modular design ensures flexibility in setup for various imaging needs.
How is this radiographic system supplied, and what are its usage options?
The system is supplied as a complete Class II radiographic unit, including the tubestand, tabletop, and wall-mounted component. Facilities can choose to use it in single-use or reusable settings, depending on their infection control protocols and operational requirements. The flexibility allows for tailored implementation based on clinical workflows.
Is this radiographic system MRI-safe, and what regulatory approvals does it hold?
The XMC-S Tubestand XMT-S Table Radiographic System is not classified as MRI-safe. It holds Traditional 510(k) clearance (K842094) from the FDA under the regulatory pathway for radiographic tables, specifically regulated under FDA regulation number 892.1980. This clearance confirms its substantial equivalence to predicate devices.
What storage and maintenance guidelines should be followed for this system?
Storage and maintenance of this radiographic system follow standard protocols for radiographic equipment. Components should be stored in a clean, dry environment to prevent damage or contamination. Regular inspections and adherence to manufacturer guidelines ensure optimal performance and longevity. Facility protocols for cleaning and disinfection should be applied based on whether the system is used in single-use or reusable settings.
What distinguishes this system from other radiographic tables?
This system is distinguished by its modular design, combining a dedicated tubestand (XMC-S), tabletop (XMT-S), and wall-mounted component (XMH-NT) into a cohesive unit. The integration of these components allows for precise patient positioning and equipment alignment, tailored specifically for stationary radiographic imaging. This modularity ensures adaptability to various clinical setups.