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The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system.

The sterile TargetScan system. This kit (K041638) includes The Biopsy Needle and the needle guide (K041637) containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan® transrectal probe Model #TS-360-P (K041639) an anesthesia administration needle and a latex probe cover that were included in the original 510(k) are now optional components of the kit and are currently not included. These items are still recommended and can be readily obtained from other sources.

This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound system. This device is indicated for performing planned and targeted ultrasound guided transrectal many I his device is indicated for performing plantive and with the Envisioneering TargetScan model TS-360-P probe.

The sterile TargetScan™ biopsy kit is designed to be used with the Targetscan™ Transrectal Ultrasound system. This kit includes a needle guide containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. This needle guide is the subject of a separate submission. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan™ transrectal probe Model #TS-360-P, which is the subject of a separate submission. An anesthesia administration needle which can negotiate the curved needle guide and a latex probe cover are included in the kit as well.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (prostate), Transrectal. This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland. This imaging can be used to guide other procedures such as biopsy of the prostate.

The TargetScan™ Transrectal Ultrasound system is intended for diagnostic prostate applications. The TargetScan™ Transrectal Ultrasound system allows the probe to remain stationary inside the patient while the user controls the position of the scan planes that are displayed on the monitor. The probe design allows the capture of transverse and longitudinal scan planes. The system is PC based allowing comprehensive imaging, planning, targeting and data storage/ retrieval.

This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system. This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.

The sterile TargetScan™ Biopsy needle Guide is designed to be used with the Targetscan™ Transrectal Ultrasound system. This needle guide contains a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. It allows a flexible biopsy needle to be directed into the tissue at an angle to the probe shaft. This needle quide is intended for use with the TargetScan™ transrectal probe Model #TS-360-P which is the subject of a separate submission.