FDA-cleared K211803
HealthPPT
Zebra Medical Vision Ltd.
Authorized purpose: Aid assessment and triage of adult frontal chest X-rays with suspected pneumoperitoneum.
- Modality
- X-ray/Radiography
- Anatomy
- Chest
- Decision
- 2021-12-15
Vendor
Zebra Medical Vision Ltd.
9 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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FDA-cleared K210085
HealthCCSng
Zebra Medical Vision Ltd.
Authorized purpose: Non-invasive post-processing to evaluate calcified coronary plaques and estimate a coronary artery calcium category.
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular; coronary arteries and calcified plaques
- Decision
- 2021-09-15
FDA-cleared K202487
HealthJOINT
Zebra Medical Vision Ltd.
Authorized purpose: Uses AI to reconstruct bones in three dimensions from two-dimensional radiographs for preoperative knee orthopedic planning.
- Modality
- X-ray/Radiography
- Anatomy
- Knee
- Decision
- 2020-12-04
FDA-cleared K200905
HealthMammo
Zebra Medical Vision Ltd.
Authorized purpose: Provides passive prioritization-only parallel workflow for suspicious findings in 2D FFDM screening mammograms.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2020-07-16
FDA-cleared K192901
HealthVCF
Zebra Medical Vision Ltd.
Authorized purpose: 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 compression fracture; it does not provide diagnosis or replace full evaluation.
- 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.
Authorized purpose: Provides adult chest X-ray workflow triage for suspected pleural effusion.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2019-11-26
FDA-cleared K190424
HealthICH
Zebra Medical Vision Ltd.
Authorized purpose: 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.
Authorized purpose: Automatically analyzes PA/AP chest X-rays for suspected pneumothorax and alerts PACS or a worklist.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2019-05-06
FDA-cleared K172983
HealthCCS
Zebra Medical Vision Ltd.
Authorized purpose: Non-invasive post-processing to evaluate coronary calcified plaques and generate a total coronary-calcium risk category.
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2018-06-13