FDA-cleared K243331

LVivo Seamless

DiA Imaging Analysis Ltd.

Offline automatic selection of echocardiographic clips for EF and GLS analysis with results sent to PACS for professional review.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2025-03-06
FDA-cleared K243235

LVivo Software Application

DiA Imaging Analysis Ltd.

Automated echo DICOM LV and RV function and contrast-EF, strain, wall-motion, bladder-volume and quality-score support.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2025-03-03
FDA-cleared K240553

LVivo Software Application

DiA Imaging Analysis Ltd.

Non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function in patients with suspected disease, with...

Modality
Ultrasound
Anatomy
Heart and cardiovascular structures, especially the left and right ventricles; a bladder-volume module is also described
Decision
2024-10-04
FDA-cleared K240769

LVivo IQS

DiA Imaging Analysis Ltd.

Provide real-time right-ventricle image-quality feedback during point-of-care or routine echocardiography acquisition.

Modality
Ultrasound
Anatomy
Right ventricle from the apical four-chamber view; the broader platform indication refers to structures and function in patients with suspected disease
Decision
2024-05-24
FDA-cleared K222970

LVivo IQS

DiA Imaging Analysis Ltd

Non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of structures and function in patients with suspected disease, with Quality Score...

Modality
Ultrasound
Anatomy
Heart; left ventricle from the four-chamber apical view
Decision
2023-02-01
FDA-cleared K202546

LVivo Seamless

DiA Imaging Analysis Ltd

LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...

Modality
Ultrasound
Anatomy
Structures and function represented in supported ultrasound examinations
Decision
2020-09-29
FDA-cleared K200232

LVivo Software Application

DiA Imaging Analysis Ltd

LVivo Software Application processes ultrasound clips and supports the labeled LVivo EF, SG, SAX, RV, and Bladder measurements and analyses, with user review and editing of...

Modality
Ultrasound
Anatomy
Cardiac structures, right and left ventricles, bladder, and other supported ultrasound anatomy
Decision
2020-06-23