DiA Imaging Analysis Ltd. radiology AI products

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FDA-cleared K243862

LVivo Software Application

DiA Imaging Analysis Ltd.

Authorized purpose: Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2025-03-17

FDA-cleared K243331

LVivo Seamless

DiA Imaging Analysis Ltd.

Authorized purpose: 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

Cardiac imaging Ultrasound workflow

FDA-cleared K243235

LVivo Software Application

DiA Imaging Analysis Ltd.

Authorized purpose: 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

Cardiac imaging Ultrasound workflow

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 Quality Score feedback.

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

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-cleared K240769

LVivo IQS

DiA Imaging Analysis Ltd.

Authorized purpose: 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

Ultrasound workflow

FDA-cleared K222970

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 feedback; the submitted IQS module provides real-time quality scoring for the left ventricle from the four-chamber apical view.

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

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-cleared K212466

LVivo Seamless

DiA Imaging Analysis Ltd

Non-invasive processing of ultrasound images to detect, measure, and calculate relevant parameters of structures and function in patients with suspected disease aged over 18.

Modality: Ultrasound
Anatomy: Exact anatomy wording was withdrawn pending re-verification.
Decision: 2021-12-09

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K210053

LVivo Software Application

DiA Imaging Analysis Ltd

Authorized purpose: LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with suspected disease.

Modality: Ultrasound
Anatomy: Structures and function represented in supported ultrasound examinations
Decision: 2021-02-05

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K202546

LVivo Seamless

DiA Imaging Analysis Ltd

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

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

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K200232

LVivo Software Application

DiA Imaging Analysis Ltd

Authorized purpose: 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 supported studies.

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

Cardiac imaging Quantification and segmentation Ultrasound workflow