Kalare Diagnostic X-Ray Table System

• • Terminated Z-1598-2013 FDA Class II ·initiated 3 Apr 2013

  Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.

510(k) Number

K110785 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Vantage Titan 3T, MRT-3010/A7, M-Power GX Open recall

  Class II

  FDA 510(k) K172878 Active Cleared 17 Nov 2017

• Aplio Artida Diagnostic Ultrasound System

  Class II

  FDA 510(k) K121577 Active Cleared 22 Jun 2012

• Vantage Titan 3T

  Class II

  FDA 510(k) K102489 Active Cleared 2 Aug 2011

• 4CH Flex Speeder

  Class II

  FDA 510(k) K112366 Active Cleared 15 Sep 2011

• Octave Speeder Head

  Class II

  FDA 510(k) K121910 Active Cleared 17 Aug 2012

• Infinix Cf-I/Sp and Infinix Vf-I/Sp Model Infx-8000V

  Class II

  FDA 510(k) K112054 Active Cleared 5 Aug 2011

See all devices from Toshiba Medical Systems Corporation, Japan →

• What types of diagnostic procedures is the Kalare Diagnostic X-Ray Table System primarily used for in a clinical setting?

  The Kalare Diagnostic X-Ray Table System is designed for fluoroscopic imaging, making it ideal for procedures requiring real-time visualization of internal structures. This includes contrast-enhanced studies like barium studies and cystograms, which are commonly performed in radiology departments to examine the gastrointestinal tract, urinary system, or other anatomical areas.

• Is the Kalare Diagnostic X-Ray Table System intended for single-use or reusable applications, and what maintenance is required?

  The Kalare Diagnostic X-Ray Table System is supplied as a reusable device, meaning it is not designed for single-use. Proper sterilization and maintenance protocols must be followed to ensure patient safety and imaging accuracy, as outlined in the manufacturer’s guidelines.

• What types of patient positioning adjustments are available on the Kalare Diagnostic X-Ray Table System?

  The system features a motorized table with adjustable positioning capabilities, allowing for precise and easy patient positioning during fluoroscopic examinations. This functionality supports a range of diagnostic procedures by accommodating different patient sizes and anatomical needs.

• How is the regulatory status of the Kalare Diagnostic X-Ray Table System determined, and what does this mean for purchasing or clinical use?

  The Kalare Diagnostic X-Ray Table System is classified under FDA regulation 21 CFR 892.1650 as a Class II medical device and holds an FDA 510(k) clearance (K110785). This means it has been deemed substantially equivalent to a legally marketed predicate device and meets the necessary safety and performance standards for use in radiology departments in the U.S.

• Does the Kalare Diagnostic X-Ray Table System have any specific safety considerations related to its use in medical imaging environments?

  The system adheres to MRI safety standards for non-MRI environments, ensuring compatibility with typical radiology department settings. However, it is not intended for use within MRI machines or areas with strong magnetic fields, as this could compromise its functionality or safety.