Undistat With Explorator 35 (UCS 35E)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K883153 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the UNDISTAT WITH EXPLORATOR 35 (UCS 35E) in a radiology department?

  The UNDISTAT WITH EXPLORATOR 35 (UCS 35E) is a radiographic, tilting table designed to provide adjustable positioning and stability for patients during X-ray imaging. Its purpose is to ensure optimal image capture by securely supporting patients in various orientations, improving the quality and accuracy of radiographic procedures in radiology settings.

• Is the UNDISTAT WITH EXPLORATOR 35 (UCS 35E) intended for single-use or reusable applications?

  The UCS 35E is supplied as a reusable system, meaning it is built for repeated use in radiology departments. Like all reusable medical devices, it requires proper maintenance and calibration to ensure safety, performance, and compliance with regulatory standards.

• How was the FDA clearance for this device determined, and what does that mean for its regulatory status?

  The UCS 35E holds an FDA 510(k) clearance (K883153) under the Traditional 510(k) review pathway, with a decision labeled as *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, confirming its compliance with Class II regulatory requirements for radiographic tables. The clearance was granted in 1988 and remains valid under ongoing regulatory oversight.

• What regulatory product code and classification apply to the UNDISTAT WITH EXPLORATOR 35 (UCS 35E)?

  The device is classified under FDA product code IXR (Radiographic Tables) and falls within Class II of medical devices, as specified in regulation 21 CFR 892.1980. This classification reflects its role in radiographic imaging procedures, requiring compliance with performance standards and post-market surveillance.

• Does the UCS 35E require any special handling or storage conditions?

  While the provided data does not specify exact storage conditions, as a reusable radiographic table, the UCS 35E should be stored in a clean, dry environment to prevent contamination or damage. Regular maintenance, including lubrication of moving parts and periodic inspections, is critical to ensure its functionality and compliance with safety standards before each use.