Search Results
Found 2738 results
510(k) Data Aggregation
(236 days)
Ask a specific question about this device
(14 days)
Ask a specific question about this device
(30 days)
Ask a specific question about this device
(81 days)
Ask a specific question about this device
(183 days)
Ask a specific question about this device
(265 days)
Ask a specific question about this device
(28 days)
Ask a specific question about this device
(138 days)
The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:
• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
• Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
- Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes
- All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use
This device is intended for single use only.
The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging or MRI-Derived Synthetic CT data. Patient-Specific Bone Models may also be provided.
N/A
Ask a specific question about this device
(91 days)
FAQ™ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light
Not Found
N/A
Ask a specific question about this device
(357 days)
a) EG-S100XT
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.
A. Intended Use/Indications for Use
a) EG-S100XT
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope. For information on indications for use, refer to the operation manuals of compatible FUJIFILM single-use endoscopes.
B. Technological characteristics
a) EG-S100XT
This product is upper gastrointestinal endoscope, is inserted into a lumen, coelom, body cavity, or the inside of the body to provide these regions images for observation, diagnosis, and treatment. This product is inserted through the oral. The flexible tube (hereinafter "the insertion tube") follows the figure of the upper gastrointestinal tract performing a bending operation. The tip of the endoscope reaches to the duodenum. It is used for observation, diagnosis, and treatment of the esophagus, stomach, and duodenum.
Insertion portion of this product has a mechanism (hereinafter "the bending section") which bends the tip from right to left and up and down, and the insertion tube consists of the bending section and operating portion with a knob which controls the bending section. The instrument channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the endotherapy device. This product is a sterile, single-use device and not intended to be reprocessed.
b) VS-1000
This product has image processing, light source control, AE (shutter) control functions, a connector for endoscopes, and a connector for display units, and provides images for observation, diagnosis, photography, or treatment in body cavities by connecting the display unit and endoscope.
C. Principles of Operation
a) EG-S100XT
The Endoscope Model EG-S100XT function on the same principles of operation as the predicate device.
This product is lighted by LED at the tip. Its reflection forms an image on CMOS image sensor through a group of object lens placed and set in the tip of this product. An electric signal from CMOS image sensor is transmitted to the processor connected to this product. The processor converts it to a video signal and displays an image on a monitor.
It is possible to do endoscopic fulguration, which enable a user to apply high-frequency electric current to objective regions inserting a high-frequency endotherapy device into the instrument channel of the operating portion. Since there are no exposed metal parts (conductive parts) on the endoscope surface that can be contacted in use, the endoscope can safely perform procedures using high-frequency current.
b) VS-1000
The product controls the light source mounted on the endoscope, receives electrical signals output from the endoscope's image sensor and outputs them as video signals to the display unit after performing image processing such as colour and image quality correction and enhancement.
The display unit's operating console and the endoscope application software built into the display unit are used to manage patient information, adjust white balance, and provide images and patient information to network devices.
N/A
Ask a specific question about this device
Page 1 of 274