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The SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

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The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

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The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a lumpectomy site intended for surgical removal.

SAVI Scout Reflector and SAVI Scout System

The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 7 days) mark a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (SGS System) the SGS Tissue Marker is located and surgically removed with the target tissue. The SGS System is intended only for the non-imaging detection of the "SGS Marker" that has been implanted in a lumpectomy site intended for surgical removal.

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The Cianna Medical Permanent Tissue Marker is intended to mark tissue during a percutaneous breast biopsy procedure and be permanently visible by radiography and visible for up to thirty days by ultrasound.

The Cianna Medical Permanent Tissue Marker and Delivery System consists of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) within the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging. The Cianna Medical Permanent Tissue Marker and Delivery System is provided sterile, and is for single use only.

The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (< 30 days) mark a lumpectomy site intended for surgical removal. Using ultrasound or radiography imaging guidance, the Cianna Tissue Marker is located and surgically removed with the target tissue.

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.

The Cianna S1, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

The Cianna S1 Single Lumen Balloon Applicator is a specialized applicator that is temporarily inserted into the target volume to facilitate the application of radiation to the target site in the treatment of carcinoma. The Cianna S1 Single Lumen Balloon Applicator is provided sterile for single use and is disposable.

The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

The SAVI Preparation Device is a specialized catheter with an inflatable balloon at the distal end. The SAVI Preparation Device is temporarily implanted in the lumpeon at the access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytheray applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator. The SAVI Preparation Device is provided sterile for single use and is disposable.

The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.

The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.