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Clear Guide SCENERGY

FDA 510(k)

Class II (US FDA 510(k))

510(k) K234030

by Clear Guide Medical

Identifiers

510(k) Number
K234030 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Clear Guide SCENERGY is a medical imaging navigation system designed for real-time instrument tracking and ultrasound-guided procedures. It integrates with DICOM volumes to provide automated segmentation and one-step registration, enabling precise fusion of imaging data for procedural guidance.

This device is used in operating suites to enhance procedural accuracy and reduce risks by updating guidance and fusion information in real-time without recalibration. Supplied as a reusable system, it requires sterile handling and is intended for use with MRI-compatible instruments. Authorized under FDA 510(k) clearance (K234030), it adheres to regulatory standards for radiology applications and instrument navigation.

Frequently asked questions

How does the Clear Guide SCENERGY improve accuracy during ultrasound-guided procedures compared to traditional methods?

The Clear Guide SCENERGY enhances accuracy by integrating real-time instrument tracking with DICOM volumes, enabling automated segmentation and one-step registration. This allows for immediate fusion of imaging data without recalibration, updating guidance dynamically during procedures. The system is designed for MRI-compatible instruments, ensuring compatibility with advanced imaging environments while reducing risks associated with manual alignment or repeated calibration.

Is the Clear Guide SCENERGY system reusable, and what precautions must be taken during use?

Yes, the Clear Guide SCENERGY is supplied as a reusable system, meaning it can be used across multiple procedures. Since it requires sterile handling, users must follow strict aseptic techniques to maintain sterility between uses. This ensures patient safety and compliance with medical imaging standards, particularly in operating suites where precision and contamination control are critical.

What types of instruments are compatible with the Clear Guide SCENERGY, and how does this affect procedure planning?

The Clear Guide SCENERGY is specifically designed for use with MRI-compatible instruments, which allows it to function seamlessly within MRI environments. This compatibility ensures that procedures involving MRI-guided interventions—such as biopsies, ablations, or other targeted therapies—can leverage real-time tracking and imaging fusion without interference. Clinicians can plan procedures with confidence, knowing the system will adapt to MRI-safe tools while providing precise navigation.

How does the real-time tracking feature of the Clear Guide SCENERGY benefit operating room workflows?

The real-time tracking feature eliminates the need for recalibration during procedures, streamlining workflows by providing continuous, up-to-date guidance. This reduces downtime and minimizes disruptions, allowing surgeons to focus on precision without frequent interruptions for alignment checks. The automated segmentation and fusion of imaging data further enhance efficiency, making it ideal for complex or time-sensitive interventions in the operating suite.

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: Clear Guide SCENERGY - Clear Guide Medical, Clear Guide Medical - Imaging Solutions, Clear Guide Scenergy-tp, Clear Guide Medical Receives FDA Clearance for CLEAR GUIDE SCENERGY ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clear Guide Medical

Sources (1)

  • FDA 510(k) K234030 24 fields · synced Sep 19, 2026