Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

The Aplio i900, i800, and i700 Software V8.1 diagnostic ultrasound systems aim to provide enhanced visualization and diagnostic information across diverse clinical applications through multi-modal imaging capabilities and a wide range of transducer compatibility. This iteration introduces significant software advancements, including Left Atrial Appendage analysis, Strain Ratio Measurement, Ultra Wideview for 4D, and EUS transducer integration, all validated to improve workflow and diagnostic utility.

The Aplio i900, Aplio i800, and Aplio i700 Software V8.1 are mobile diagnostic ultrasound systems designed for visualizing anatomical structures and dynamic physiological processes within the human body to aid in diagnosis across a wide array of clinical applications. These applications encompass fetal, abdominal, pediatric, small organs, cardiovascular, musculoskeletal, and specialized imaging such as trans-vaginal, trans-rectal, transesophageal, intra-operative, laparoscopic, and thoracic/pleural assessments. The systems utilize various probes, including flat linear array, convex, and sector array types, operating at frequencies from approximately 2MHz to 33MHz, and support numerous imaging modes like B-mode, M-mode, Doppler (Continuous Wave, Color, Pulsed Wave, Power, Combination), Speckle-tracking, Tissue Harmonic Imaging, Shear wave, Elastography, and Acoustic attenuation mapping. Notably, the Aplio i800 model, when paired with the EUS transducer GF-UCT180, extends its diagnostic capabilities to the upper gastrointestinal tract and surrounding organs. The V8.1 software iteration introduces several new features and enhancements to these ultrasound systems. Key additions include Left Atrial Appendage (LAA) Analysis for assessing LAA dimensions and generating shape models, which clinical testing confirmed improves workflow and provides measurements useful for planning transcatheter LAAO procedures. A Strain Ratio Measurement functionality has been incorporated into strain elastography, with phantom studies demonstrating its accuracy in calculating strain ratios comparable to known elasticity values. Ultra Wideview support has been extended to the Mecha4D transducer (PVT-675MVS), thereby increasing the scan range in 4D mode. Furthermore, a CEUS viewer has been added for reviewing stored contrast exam images, and the Olympus EUS transducer GF-UCT180 has been successfully integrated with the Aplio i800 model. Non-clinical and clinical testing validated that these new and improved features meet established specifications and perform as intended, offering equivalent or enhanced diagnostic utility.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the 'Left Atrial Appendage (LAA) Analysis' feature in Software V8.1 specifically improve upon existing manual LAA assessment workflows in terms of accuracy, reproducibility, and time efficiency for planning transcatheter LAAO procedures?; What are the quantitative benefits and potential limitations of the 'Strain Ratio Measurement' for strain elastography in distinguishing between different tissue stiffness, particularly in challenging anatomical regions or diverse patient populations?; Can the 'Ultra Wideview Support for Mecha4D' with the PVT-675MVS transducer significantly enhance diagnostic capabilities or procedural guidance in specific clinical scenarios, such as fetal imaging or complex vascular assessments, beyond standard field-of-view limitations?; Regarding the integration of the Olympus EUS transducer GF-UCT180 with the Aplio i800/E3, what are the key image quality enhancements or novel diagnostic insights this combination provides for upper gastrointestinal and surrounding organ pathologies compared to previous EUS systems or the predicate device without this specific transducer?; What specific advancements or algorithms underpin the 'Acoustic attenuation mapping' feature in these systems, and how do these contribute to improved tissue characterization or diagnostic confidence in applications like liver steatosis assessment?