Clarius Mobile Health Corp. radiology AI products

Clarius OB AI assists a trained and qualified healthcare professional with measurements of fetal biometric parameters, including head circumference, abdominal circumference, femur...

Modality: Ultrasound
Anatomy: Fetal anatomy and fetal biometric landmarks
Decision: 2024-06-14

Quantification and segmentation Ultrasound workflow

FDA-cleared K232257

Clarius Bladder AI

Clarius Mobile Health Corp.

Provide semi-automatic, non-invasive bladder-volume measurements from ultrasound data acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; a...

Modality: Ultrasound
Anatomy: Bladder
Decision: 2023-11-13

Quantification and segmentation Ultrasound workflow

FDA-cleared K232704

Clarius Ultrasound Scanner

Clarius Mobile Health Corp.

The Clarius Ultrasound Scanner is a software-based, transportable ultrasound imaging system for diagnostic ultrasound imaging and fluid-flow analysis across the labeled...

Modality: Ultrasound
Anatomy: Ophthalmic, fetal, abdominal, intraoperative non-neurological, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, gynecologic, cardiac, peripheral-vessel, carotid, and needle-guidance anatomy
Decision: 2023-10-05

Cardiac imaging Ultrasound workflow

FDA-cleared K222406

Clarius AI

Clarius Mobile Health Corp.

Clarius AI semi-automatically places calipers for non-invasive measurements of musculoskeletal structures on ultrasound data acquired by the Clarius Ultrasound Scanner.

Modality: Ultrasound
Anatomy: MSK
Decision: 2023-01-23

Quantification and segmentation Ultrasound workflow

FDA-cleared K213436

Clarius Ultrasound Scanner

Clarius Mobile Health Corp.

Clarius Ultrasound Scanner is a general-purpose diagnostic ultrasound system for trained healthcare professionals across the labeled fetal, abdominal, pelvic, small-organ,...

Modality: Ultrasound
Anatomy: Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic anatomy
Decision: 2021-11-15

Cardiac imaging Ultrasound workflow

FDA-cleared K192107

Clarius Ultrasound Scanner

Clarius Mobile Health Corp.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and...

Modality: Ultrasound
Anatomy: Ophthalmic, fetal, abdominal, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, gynecologic, cardiac, peripheral-vessel, carotid, and needle-guidance anatomy
Decision: 2019-08-29

Cardiac imaging Ultrasound workflow

FDA-cleared K180799

Clarius Ultrasound Scanner

Clarius Mobile Health Corp.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and...

Modality: Ultrasound
Anatomy: Ophthalmic, fetal, abdominal, intraoperative, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, gynecologic, cardiac, peripheral-vessel, carotid, and needle-guidance anatomy
Decision: 2018-05-14

Cardiac imaging Ultrasound workflow

FDA-cleared K172385

Clarius Ultrasound System

Clarius Mobile Health Corp.

Clarius Ultrasound Scanner is a software-based diagnostic ultrasound imaging system for trained healthcare professionals across labeled abdominal, thoracic, musculoskeletal,...

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2017-09-14

Breast imaging Cardiac imaging Ultrasound workflow

FDA-cleared K163138

Clarius Ultrasound System

Clarius Mobile Health Corp.

The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories for point-of-care imaging of medical conditions, including emergency triage for trauma,...

Modality: Ultrasound
Anatomy: General human-body anatomy; listed point-of-care ultrasound applications
Decision: 2016-11-30

Cardiac imaging Acute triage and notification Ultrasound workflow