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The Endomag Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomaq Maqseed® Magnetic Marker is intended for use as a tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The Magseed Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site that is for example intended for surgical removal. The Magseed Magnetic Marker is subsequently localized by using imaging quidance (such as ultrasound or radiography) or aided by non-imaging quidance (Endomag Sentimag® System, K153044 and K163541). The marker can be detected up to 3cm from the Sentimag® probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

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

The Sentimag System is intended for the non-imaging detection and localization of the Sentimark Magnetic Marker that has been implanted in a lumpectomy site intended for surqical removal. The Sentimag System and Sentimark Magnetic Marker System are designed for use in an operating room environment by suitably trained physicians who are experienced in diagnosis and treatment of breast lesions. The Sentimag System aids the surgeon to detect surgically invasively magnetic marker material that has been placed for the purpose of detecting a non-palpable lesion, and to locate target excision sites. Prior to a lumpectomy procedure, the Sentimark Magnetic Marker is placed percutaneously into the breast, using imaging quidance such as ultrasound or radiography, to temporarily mark a site intended for surgical removal. During a surgical procedure, the hand-held Sentimaq probe emits an alternating magnetic field that detects the magnetic response of the Sentimark magnetic marker, this signal is converted by the base unit into a visual and audible response that is similar in use to the predicate device.