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StentBoost Rel. 4

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132305

by Philips Medical Systems Nederland B.V.

Identifiers

510(k) Number
K132305 FDA 510(k)
FDA Product Code
OWB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The StentBoost Rel. 4 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during percutaneous coronary interventions. It provides high-resolution fluoroscopy to guide stent placement and other endovascular procedures with precision, supporting diagnostic and therapeutic radiology applications.

This system is supplied as a reusable medical device, intended for use in clinical radiology settings. It is classified as Class II under FDA regulations (892.1650) and has received FDA 510(k) clearance and MDR authorization. The device is not MRI-safe and requires proper storage and maintenance as specified by the manufacturer to ensure performance and sterility.

Frequently asked questions

What is the StentBoost Rel. 4 primarily used for in clinical settings?

The StentBoost Rel. 4 is an interventional fluoroscopic X-ray system designed specifically for real-time imaging during percutaneous coronary interventions. It provides high-resolution fluoroscopy to guide precise stent placement and other endovascular procedures, supporting both diagnostic and therapeutic radiology applications in clinical radiology settings.

Is the StentBoost Rel. 4 a single-use or reusable device, and how does this affect its maintenance?

The StentBoost Rel. 4 is a reusable medical device, meaning it is intended for repeated use in clinical settings. Since it is reusable, proper storage and maintenance as specified by Philips Medical Systems are required to ensure performance, sterility, and longevity. This includes regular cleaning, calibration, and servicing to comply with manufacturer guidelines.

What regulatory pathways has the StentBoost Rel. 4 followed, and what does this mean for its use?

The StentBoost Rel. 4 has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization. This means the device has undergone evaluation by regulatory bodies to confirm its safety, effectiveness, and compliance with applicable standards before being approved for use in the United States and European markets, respectively.

Can the StentBoost Rel. 4 be used in an MRI environment, and why is this important?

No, the StentBoost Rel. 4 is explicitly stated as not MRI-safe. This is important because using non-MRI-safe devices in or near an MRI environment can pose serious risks, such as interference with imaging or physical harm to patients and staff due to magnetic forces or radiofrequency emissions.

What classification does the StentBoost Rel. 4 hold under FDA regulations, and what does this imply?

The StentBoost Rel. 4 is classified as a Class II medical device under FDA regulations (892.1650). This classification indicates that the device is subject to special controls to ensure its safety and effectiveness, such as performance standards, post-market surveillance, and labeling requirements, but does not require the stringent pre-market approval process of Class III devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K132305 - STENTBOOST REL. 4 FDA 510 (k) APPLICATION FOR PHILIPS MEDICAL ..., STENTBOOST REL. 4 510 (k) K132305 - FDA.report, FDA Browser - Cleared 510 (K) - STENTBOOST REL. 4 (K132305), PDF K132305 - Stentboost Rel, PDF Regulatory Affairs Specialist Veenpluis 4-6 5684 PC Best

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.

Sources (2)

  • FDA 510(k) K132305 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026