FDA-cleared K172983

HealthCCS

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-06-13
FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2019-06-13
FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

Image analysis/processing for Chest/Lung using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-11-26
FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-05-12
FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-07-16
FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2020-12-04
FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2021-09-15