FDA-cleared K211803

HealthPPT

Zebra Medical Vision Ltd.

The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Raycases with features suggestive of pneumoperitoneum in the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-12-15
FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

The HealthCCSng is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2021-09-15
FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

The Zebra HealthJOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2020-12-04
FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2020-07-16
FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral...

Modality
CT/CTA
Anatomy
Vertebral bodies and spine as seen on chest and abdominal CT; suspected vertebral compression fractures
Decision
2020-05-12
FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-ray cases with features suggestive of pleural effusion in the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-11-26
FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.

Modality
CT/CTA
Anatomy
Head/brain
Decision
2019-06-13
FDA-cleared K190362

HealthPNX

Zebra Medical Vision Ltd.

The Zebra Pneumothorax device is a software tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-05-06
FDA-cleared K172983

HealthCCS

Zebra Medical Vision Ltd.

The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2018-06-13