The Mendaera Guidance System ("Study Device") is intended to provide guidance for precise instrument placement of common percutaneous devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. After instrument placement is achieved, investigator will perform any further clinical tasks, procedures, or treatment using standard of care.
The target population for whom this device is intended includes participants requiring ultrasound guided, percutaneous procedures.
Participants who are scheduled to undergo an ultrasound-guided procedure will be consented and enrolled in the study.
Prior to the study procedure, participants should be prepared for ultrasound-guided procedure using standard of care.
Once the investigator determines that an ultrasound-guided procedure can be performed, the compatible percutaneous instrument will be connected to the Study Device, and the investigator may proceed to utilize the System to perform targeting and depth tracking of the instrument. Once access has been achieved, Participation will conclude after the first follow-up which is anticipated to be within 24±12 hours.