Remote Controlled X-Ray Diagnostic RS-110

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

510(k) Number

K905153 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Shimasonic Linear/Convex Diagnostic Ultrasound System

  Class II

  FDA 510(k) K973802 Active Cleared 4 Mar 1998

• Shimadzu Whole Body X-Ray CT Scanner Sct-7000TX

  Class II

  FDA 510(k) K955255 Active Cleared 9 Feb 1996

• Shimadzu X-Ray High-Voltage Generator XUD150K

  Class I

  FDA 510(k) K911339 Active Cleared 16 Apr 1991

• Shimadzu X-Ray High-Voltage Generator XUD150B

  Class I

  FDA 510(k) K911280 Active Cleared 17 Jun 1991

• Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000TX W/Fluro Option

  Class II

  FDA 510(k) K984156 Active Cleared 21 Apr 1999

• MU125M Mobile X-Ray System

  Class II

  FDA 510(k) K920393 Active Cleared 6 Apr 1992

See all devices from Shimadzu Medical Systems →

• What is the Shimadzu RS-110 Remote Controlled X-Ray Diagnostic used for?

  The RS-110 is a radiographic table designed for remote-controlled radiography and fluoroscopy. It allows operators to manipulate the system from a distance, reducing their exposure to X-rays while enabling real-time imaging of internal body structures. This setup enhances procedural flexibility, particularly in diagnostic imaging where precise positioning is critical.

• Is the RS-110 supplied sterile or reusable?

  The RS-110 is supplied as a reusable, non-sterile medical instrument. It is intended for repeated use in radiology departments, with maintenance and cleaning following manufacturer guidelines to ensure proper functionality and safety.

• What power configurations does the RS-110 support?

  The RS-110 is compatible with three-phase power ratings, such as 800 mA x 125 kVp. This ensures it can operate within standard radiology environments while delivering consistent imaging performance.

• Does the RS-110 include any special features for operator safety?

  Yes, the RS-110 features remote control functionality, which significantly reduces operator radiation exposure during X-ray procedures. Additionally, it adheres to standard MRI safety guidelines for Class 2 devices, ensuring compatibility with radiology workflows.

• How is the RS-110 regulated and approved?

  The RS-110 is regulated under the FDA 510(k) clearance pathway with the reference number K905153. It was granted clearance through a traditional review process by the Radiology (RA) Advisory Committee, confirming its substantial equivalence to predicate devices.