Elite 1500 Radiographic Tilting Table

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

510(k) Number

K896324 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DW250 #91

  Class II

  FDA 510(k) K944557 Active Cleared 3 Nov 1994

• The Vivacare T.P.S. Probe

  Class I

  FDA 510(k) K944848 Active Cleared 14 Dec 1994

• Ext-600 Table, Radiographic, Elevating

  Class II

  FDA 510(k) K896665 Active Cleared 22 Jan 1990

• Rms 90/15 Radiographic/Fluoroscopic Tilting Table

  Class II

  FDA 510(k) K896119 Active Cleared 27 Nov 1989

• Rms K-Wire

  Class II

  FDA 510(k) K963367 Active Cleared 30 Oct 1996

• Elite R/F Spot Film Drive

  Class II

  FDA 510(k) K902403 Active Cleared 1 Aug 1990

See all devices from Rms Div. →

• Is the Elite 1500 Radiographic Tilting Table intended for single-use or can it be reused in a clinical setting?

  The Elite 1500 Radiographic Tilting Table is explicitly designed as a reusable medical device for use in radiology departments. Since it is not labeled as sterile or single-use, it must be properly cleaned and maintained between procedures to ensure patient safety and device integrity.

• What types of imaging procedures is this table primarily used for, and why is the tilting feature important?

  The Elite 1500 Radiographic Tilting Table is intended for radiographic and fluoroscopic procedures, where precise patient positioning is critical. The tilting mechanism allows clinicians to adjust the patient’s angle for optimal imaging, improving the quality and accuracy of diagnostic images in settings like X-ray and fluoroscopy.

• How is this device regulated, and what does the FDA clearance classification (IXR) indicate about its intended use?

  The Elite 1500 Radiographic Tilting Table is classified under FDA 510(k) clearance as a Class II device with the product code IXR (Imaging, Radiographic). This classification confirms it is intended for diagnostic imaging applications where radiographic and fluoroscopic imaging are performed, ensuring it meets regulatory standards for patient safety and performance in radiology.

• Does the Elite 1500 Tilting Table come with any specific storage or handling instructions based on its reusable nature?

  While the provided data does not specify storage details, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper maintenance, including cleaning and inspection, is essential to prevent contamination and ensure longevity, though exact protocols would be outlined in the manufacturer’s instructions.

• Is there any information about the weight capacity or tilt range of this radiographic table?

  The provided data does not include specifications for the Elite 1500’s weight capacity or tilt range, so those details would need to be referenced in the manufacturer’s documentation or technical specifications. However, its design as a radiographic tilting table implies it is built for clinical use in radiology, where such parameters are typically critical for patient safety.