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The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery). Trans-raginal. Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular). Modes of Operation: - · 2D (B-Mode) (including Tissue Harmonic imaging) - · M-Mode - · Vector Flow Imaging (VFI) - Strain Elastography - · CW Doppler - · Contrast Imaging - · PWD Mode - · CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler)

The Ultrasound System 1300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a glass touchpad, a 19" Clinical display monitor (CDM). In addition to this a variety of system accessories are available such as baskets, foot switch, printer start-up kit, and extra holders.

Intended Use: The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. Indications to Use: The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cramial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

The Ultrasound System 2300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications. The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.

Intended Use: The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. Indications to Use: The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular). Modes of Operation: - 2D (B-Mode) including Tissue Harmonic Imaging - M-Mode - PWD Mode - CFM Mode (C, VFI) - Power Doppler - Contrast Imaging - CW Doppler - Strain Elastography Environment: The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices) Contraindications: The Ultrasound System 2300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound System 2300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications. The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders. The Ultrasound System 2300 is available in the following marketing configurations: - 1. bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging - 2. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications. - 3. bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical and anesthesiology applications. All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options.

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular). Contraindications: The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The transducers are all multi-frequency transducers including: - Linear Array - Phased Linear Array - Convex / Curved Array The interaction with the patients is dependent upon the transducer type which may be: - Surface Contact. - Intra-operative, - Laparoscopic, or - Endocavity The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular). Contraindications: The Ultrasound System 1300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound System 1300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The initial release of the 1300 system will include the BK1500 marketing configuration model. The transducers are all multi-frequency transducers including: - Phased Linear Array - Convex / Curved Array . - Linear Array. ● The interaction with the patients is dependent upon the transducer type which may be: - Surface Contact, ● - Intra-operative, or ● - Endocavity . The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular). Contraindications: · The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eve. · The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The transducers are all multi-frequency transducers including: - Phased Linear Array 0 - o Convex/Curved linear array. The interaction with the patients is dependent upon the transducer type which may be: - 0 Surface contact. - . Intra-operative, or - 0 contact through Endocavity when used in locations as described by the indications for use. The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: ultrasound scanner and transducers for B. Tissue and Contrast Harmonic Imaging, M. PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Applications: - Fetal (Sometimes called Obstetrics) . - Abdominal ● - Intra-operative ● - Intra-operative (Neuro) (sometimes called Neuro Surgical) ● - Pediatrics . - Small Organ (Sometimes called Small Parts) . - . Neonatal Cephalic (Cephalic is sometimes called trans-cranial) - Adult Cephalic (Cephalic is sometimes called trans-cranial) ● - Trans-rectal - . Trans-vaqinal - . Trans-urethral - Musculo-skeletal (Conventional) - Musculo-skeletal (Superficial) - Cardiac Adult - Peripheral Vessel (Sometimes called Peripheral Vascular) .

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.