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The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPP
In Commercial Distribution
- B201CGTPP0 ()
- B201CGTPP1 ()
- Length: 3 Inch
- Length: 4 Inch
- Length: 5 Inch
CG-TPP
- MRI-oriented needle guide positioner
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).
CLEAR GUIDE MEDICAL, INC.
CGTPF
In Commercial Distribution
- B201CGTPF0 ()
- B201CGTPF1 ()
CG-TPF
- MRI-oriented needle guide positioner
The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGSM
In Commercial Distribution
- B201CGSM1 ()
- B201CGSM0 ()
- Intraoperative ultrasound imaging transducer cover
- Optical medical device procedural cover
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, 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).
CLEAR GUIDE MEDICAL, INC.
CGSCENERGYTP
In Commercial Distribution
- B201CGSCENERGYTP0 ()
- B201CGSCENERGYTP1 ()
CG-SCENERGY-TP
- Surgical planning/navigation-enhancement system
- Stereotactic system application software
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGPAT
In Commercial Distribution
- B201CGPAT0 ()
- B201CGPAT1 ()
CG-PAT
- MRI-oriented needle guide positioner
- Patient positioner base plate
No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution
- B201CGONE1 ()
- B201CGONE0 ()
- Ultrasound imaging system application software
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution
- B201CGOHM0 ()
- B201CGOHM1 ()
CG-OH-M
- Radiological video camera patient positioning/tracking system camera
- Optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution
- B201CGOH1 ()
- B201CGOH0 ()
CG-OH
- Radiological video camera patient positioning/tracking system camera
- Optical surgical navigation device tracking system
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution
- B201CGCORE24MR0 ()
- B201CGCORE24MR1 ()
CG-CORE24-MR
- Stereotactic surgery system workstation
- Ultrasound imaging system workstation
- Optical surgical navigation device tracking system workstation, mobile
- Panel computer