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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 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-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution
- B201CGCORE130 ()
- B201CGCORE131 ()
CG-CORE-13
- Ultrasound imaging system workstation
- Stereotactic surgery system workstation
- Optical surgical navigation device tracking system workstation, mobile
- Portable computer
Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient use disposable CPAP generator to be used on patients exhibiting acute respiratory distress.
B.L.S. Systems Limited
8710
In Commercial Distribution
- B20087101 ()
- B20087100 ()
- Small CPAP Mask
8710
- CPAP/BPAP face mask, single-use
B200 SERIES PULSE OXIMETER SENSOR
BETA BIOMED SERVICES INC
B200-1016
In Commercial Distribution
- B200101603 ()
- B2001016 ()
- Pulse oximeter, line-powered
B200 SERIES PULSE OXIMETER SENSOR
BETA BIOMED SERVICES INC
B200-1011M
In Commercial Distribution
- B2001011M03 ()
- B2001011M01 ()
- Pulse oximeter, line-powered
B200 SERIES PULSE OXIMETER
BETA BIOMED SERVICES INC
B200-1004N
In Commercial Distribution
- B2001004N03 ()
- B2001004N01 ()
- Pulse oximeter, line-powered
No Description
WALK VASCULAR L.L.C.
WVCART
Not in Commercial Distribution
- B139WVCART2 ()
- B139WVCART0 ()
- Medical device integration rack