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Esaote's Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculosketal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes. The Virtual Navigator software option for Esaote 6450 system is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto). Model 6450 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality. Model 6450 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6450 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen. Model 6450 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes. Model 6450 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port. The marketing names for Model 6450 will be MyLabX8 and MyLabX8 eXP.

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 6400 systems, (MyLabX6 and MyLabX7), are a mainframe systems equipped with wheels allowing to move the system. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6400 manages Qualitative Elastosonography (ElaXto). Model 6400 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6400 can drive Phased array, Linear array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Owerty alphanumeric keyboard that allows data entry. Model 6400 is equipped with wireless capability. Model 6400 is already cleared via K161359. The marketing name for new devices of Model 6400 will be: - MyLabX6 - . MyLabX7 MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below: - 1. Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement. - 2. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection. - 3. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination. - 4. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis. - 5. Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7. - 6. Full screen option. - 7. Windows 10 Operative System. The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

Esaote's 6420 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle. The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. 6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. 6420 is equipped with wireless capability. Model 6420 was previously cleared via K161168. The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below: - 1. Management of Strain 2D. - 2. Addition of Auto NT option. - 3. Addition Auto EF option - 4. Management of probe L 4-15. - 5. Addition of Full screen option. - 6. Operative system Windows 10 The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column. G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed to G-scan Brio, with respect to the cleared version – G-scan Brio K133490 – are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - A new Bilateral TMJ Coil - Introduction of the DPA Lumbar spine coil n° 10 with a new extra-large flexible section - Introduction of the thoracic spine section examination - A new software version including the following features: - o Customization of Image Enhancement - o Overlay sending to PACS - o Isotropic 3D acquisition

Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric and Other: Urologic. The 7410 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Model 7410 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operations are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. 7410 system can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On 7410 system the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7410 system is equipped with wireless capability. Model 7410 has been designed to be powered by battery.

S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified S-scan device, with respect to the cleared version - Sscan K121650 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - 1. Upgrading of the electronics - 2. Patient bed unlocking function - 3. A new software version

Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery. Both 6400 and 7400 have been cleared via k111302. 6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below: - 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition. - 2. Management of 3D/4D mode of operation. - 3. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan). The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis.

The OrthoCAD software option is a software package intended to be used with Esaote Gscan system cleared via K111803. OrthoCAD provides the morphometry of the lumbosacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis. G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints. The OrthoCAD system allows you to visualize, analyse and compare Magnetic Resonance images. The system is connected to a database that enables the physician to keep track of all the patients examined over time. The images are acquired by running FSE T2 Rel sequences on the G-scan of the lumbosacral tract of the vertebral spine, in the sagittal plane, and are transferred to the OrthoCAD database following acquisition. When the MR images are stored on the OrthoCAD database, the user can proceed with a manual or semi-automatic (wizard) segmentation of the vertebral bodies (from L1 up to S1) and of the spinal canal. During the segmentation of the anatomical elements, 3D models are constructed based on the segmented structures. When the segmentation procedure has been terminated, the user can proceed with the evaluation of the following significant clinical parameters: - . Vertebral wedging - Listhesis index . - Intervertebral translation index . - Intervertebral angles . - Vertebral collapse index . - . Spinal curvature - . Spinal canal thickness - . Spinal canal section - Foramen area . . Following this process, the endoscopic virtual navigation within the segmented spinal canal is enabled. Finally, if the user has worked on MR images acquired both in the clinostatic and orthostatic mode, the measures calculated and the virtual navigation of the two the positions can be compared, and a report containing all the information is produced. OrthoCAD is made up of six environments: - . Patient Management: contains the functions required for the display and management of patients stored in the database associated with the system. - Home: keeps track of the procedures executed overtime for the selected patient . (analyses present, status of examinations associated with the various analyses, etc.). - . Segmentation: carries out the functions used for the segmentation and those related to the construction of 3D models of anatomic elements - Measurements: includes all tools required to measure the clinical parameters . used for the analysis of the currently selected exam. - Navigation: enables endoscopic virtual navigation within the segmented . anatomical structures by means of the definition of anatomic points, in order to construct one (or more) navigation routes. - . Comparison: enables the comparison of two different examinations within the same analysis or within different analyses provided they are the same type. This environment enables: - . The simultaneous display, or superimposed display when required, of anatomical elements which belong to the two volumes being compared. - 미 The simultaneous display of the different measurements, with an indication of the main differences between these values.

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified G-scan device (G-scan Brio), with respect to the cleared version - G-scan K111803 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - 1. A new patient table that can be moved manually in the inner/outer direction of the gantry. - 2. A new footboard and seat for vertical examinations. - 3. A patient table extension. - 4. A back support. - 5. A new step for patient positioning. - 6. A new control panel on the front of the magnet. - 7. Upgrading of the hydraulic circuit. - 8. Upgrading of the electronics. - 9. 4-channels Lumbar spine coils N.17 and 18 introduction, cleared via K110802. - 10. A new software release.

S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf. knee. thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified S-scan device, with respect to the cleared version – S-scan K110802 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: 1. A new step for patient positioning. 2. A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18. 3. Geometric distortion correction. 4. FSE parameters optimization 5. FSE acceleration and improving. 6. FSE sampling frequency management. 7. Streaming acquisition performance increasing. 8. Configurable send and export of XBONE echoes. 9. Environment for the management of the virtual film. 10. Data matching for patient coming from a worklist server. 11. SpeedUp technique introduction, cleared via K120748. 12. A new software version.