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The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.

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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.

The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target. The needle sensor consists of a sensor head, cable and a connector.

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, sterile sheaths, ultrasound transmission gel, and bands.

The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SonixTABLET Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an optional electrocardiography (ECG) display feature and support for a 3lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased arrav scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the SonixTABLET Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The SonixTouch Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the SonixTouch Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The SONIX MDP Ultrasound System indication(s) for use are the same as the predicate devices.

The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal organs and vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, MSK Conventional, MSK Superficial, Transcranial Doppler.

The Sonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The system has an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes. The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands. The needle guides are single use (disposable).

The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays. These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.