Shimadzu Multi-Directional Diagnostic Table VS-100

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

510(k) Number

K913147 ↗

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 VS-100 Multi-Directional Diagnostic Table used for?

  The Shimadzu VS-100 is designed specifically for radiographic and fluoroscopic imaging procedures. Its multi-directional adjustments allow clinicians to optimize patient positioning, improving diagnostic accuracy by accommodating various angles and orientations during X-ray examinations. This flexibility is particularly useful in radiology departments where precise imaging is critical for accurate diagnosis.

• Is the VS-100 a single-use or reusable device?

  The Shimadzu VS-100 is supplied as a reusable medical device. Unlike single-use items, it is intended for repeated use in radiology departments after proper cleaning and maintenance. This design aligns with its classification as a reusable radiographic table, ensuring durability and cost-effectiveness for clinical settings.

• Does the VS-100 come with sterile packaging?

  The VS-100 is not classified as a sterile device and does not require sterile packaging. Since it is reusable, sterility is maintained through institutional protocols for cleaning, disinfection, and reprocessing between uses. Clinicians should follow manufacturer guidelines and facility protocols to ensure proper hygiene and safety.

• What regulatory pathway was followed for the VS-100?

  The Shimadzu VS-100 received FDA clearance under the traditional review pathway, specifically through a 510(k) submission. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory standards for radiographic tables. The device holds a classification of Class II under the product code IXR (Imaging Systems, X-Ray).

• Is the VS-100 MRI-safe or MRI-conditional?

  The VS-100 is explicitly not classified as MRI-safe or MRI-conditional. This means it should not be used in MRI environments, as its materials or construction may interfere with MRI imaging or pose risks to patients or staff. Clinicians should ensure the device is only used in radiology departments equipped for X-ray procedures.