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510(k) Data Aggregation
K Number
K234030Device Name
Clear Guide SCENERGY
Manufacturer
Date Cleared
2024-01-17
(28 days)
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Clear Guide Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
Device Description
The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).
The CLEAR GUIDE SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data. the CLEAR GUIDE SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are ning that new inputs (e.g., a new CT or MRI) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
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K Number
K201188Device Name
Clear Guide SCENERGY
Manufacturer
Date Cleared
2020-09-30
(152 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Clear Guide Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
Device Description
The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.q., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
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K Number
K201898Device Name
Clear Guide SCENERGY
Manufacturer
Date Cleared
2020-07-31
(29 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Clear Guide Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.
Device Description
The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
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K Number
K171677Device Name
Clear Guide SCENERGY
Manufacturer
Date Cleared
2017-12-08
(185 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Clear Guide Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.
Device Description
The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
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K Number
K153004Device Name
Clear Guide SCENERGY
Manufacturer
Date Cleared
2016-02-12
(122 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
CLEAR GUIDE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide Scenergy is a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities.
The Clear Guide Scenergy utilizes the Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide Scenergy might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.
Device Description
The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from ultrasound and CT modalities. The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated, and the user cannot modify either result. Segmentation results are deterministic, meaning that new inputs (e.g., a new CT) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
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K Number
K141806Device Name
CLEAR GUIDE ONE
Manufacturer
Date Cleared
2014-09-19
(78 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
CLEAR GUIDE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, and for predicting its future path on a display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.
Device Description
The Clear Guide ONE is a medical device that tracks instrument positioning during ultrasound-guided procedures to provide instrument guidance to the end user. The device attaches directly to the transducer probe, and through optical detection technology, the Clear Guide ONE identifies and tracks any needle or needle-like rigid object entering the field of view. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The Clear Guide ONE is an accessory to an existing ultrasound machine and transducer probe.
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