Multistar D Angiographic X-Ray System

• • Terminated Z-0167-2010 FDA Unclassified (pre-2012) ·initiated 1 Jul 2009

  The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.

• • Terminated Z-1437-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009

  Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

• 5 recalls, same reason

  • Terminated Z-0135-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-0142-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-0139-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-0147-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-0148-2009 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008

  Unintended movement of the system table and/or C arm.

510(k) Number

K930635 ↗

FDA product code

IZI

Device class

Class II

Regulation

21 CFR Part 892.1600

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

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• What types of medical procedures is the Multistar D Angiographic X-Ray System designed to support in a clinical setting?

  The Multistar D Angiographic X-Ray System is specifically designed for radiologic visualization of the heart, blood vessels, or lymphatic system. It captures detailed images after the injection of a contrast medium, making it suitable for diagnostic procedures such as coronary angiography, peripheral vascular imaging, and lymphatic studies in radiology departments.

• How is the Multistar D Angiographic X-Ray System supplied, and does it come with multiple configurations?

  The system is supplied as a complete angiographic X-ray system, and it includes various model-specific configurations. These configurations are indicated by the associated FEI numbers listed in the regulatory data, which represent different product variants or setups available for purchase.

• Is there any information provided about whether the Multistar D Angiographic X-Ray System is intended for single-use or reusable applications?

  The provided data does not specify whether the Multistar D Angiographic X-Ray System is intended for single-use or reusable applications. This information would need to be clarified directly with the manufacturer, as it is not detailed in the regulatory submission.

• What regulatory pathway was followed for the FDA clearance of the Multistar D Angiographic X-Ray System, and what does this mean for its use?

  The Multistar D Angiographic X-Ray System received FDA clearance under the traditional review pathway, specifically through a 510(k) submission. It was determined to be substantially equivalent to a predicate device, meaning it meets the same performance standards and safety requirements as an existing approved device, ensuring its suitability for use in radiology departments as described.

• Are there any specific storage or handling instructions provided for the Multistar D Angiographic X-Ray System?

  The provided data does not include any details regarding storage or handling instructions for the Multistar D Angiographic X-Ray System. For proper use and maintenance, it is recommended to consult the manufacturer’s official documentation or contact their support team.