MEDTRONIC MINIMED, INC. MMT-6104 MiniMed™ Mobile

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making.

qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.

Cassini Guidance System provides guidance assistance to the surgeon during eye surgeries. The device displays real-time non-diagnostic video during eye surgery on a flat panel display device positioned for live visualization by the surgeon and surgical personnel in the operating room. The Cassini Guidance System provides graphical tools to the surgeon as desired during treatment by using pre-operative clinical data and surgeon-driven, onscreen templates and tools. The system utilizes surgeon confirmation at each step to plan and position guidance tools. The system neither performs any interpretations nor provides treatment recommendations.

Burr, Oval, 10 flute, 3.0mm

SFTWR MMT-6104 MM MBL CLIN IOS 2.0.2

Operio Mobile is a clean air zone unit, with an integrateddetachable instrument tray, to be used in the operatingzone, which produces a directed, non-turbulent ultracleanair flow to the surgical site during ophthalmic,orthopedic and neuro surgery and to the sterileinstruments used during surgery.

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making.

qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.

Cassini Guidance System provides guidance assistance to the surgeon during eye surgeries. The device displays real-time non-diagnostic video during eye surgery on a flat panel display device positioned for live visualization by the surgeon and surgical personnel in the operating room. The Cassini Guidance System provides graphical tools to the surgeon as desired during treatment by using pre-operative clinical data and surgeon-driven, onscreen templates and tools. The system utilizes surgeon confirmation at each step to plan and position guidance tools. The system neither performs any interpretations nor provides treatment recommendations.