Zebra Medical Vision, Ltd.
IsraelFDA 510(k) applicant, unverified
- Devices
- 9
What Zebra Medical Vision, Ltd. makes
Zebra Medical Vision, Ltd. develops AI-powered diagnostic imaging software for radiology workflows, including chest CT (HealthCCS, HealthCCSng), chest X-ray (HealthCXR), joint imaging (HealthJOINT), pelvic CT (HealthPPT), and mammography (HealthMammo). Their solutions also analyze lung nodules (HealthPNX), vertebral compression fractures (HealthVCF), and intracranial hemorrhages (HealthICH).
All listed products fall under FDA Class II medical devices and are cleared via the 510(k) pathway. The company is based in the United States and its software solutions are registered with the FDA under this regulatory framework.
Catalogue
HealthCCS Ref K172983
510(k) 510(k)HealthICH Ref K190424
510(k) 510(k)HealthPNX Ref K190362
510(k) 510(k)HealthCXR Ref K192320
510(k) 510(k)HealthCCSng Ref K210085
510(k) 510(k)HealthJOINT Ref K202487
510(k) 510(k)HealthPPT Ref K211803
510(k) 510(k)HealthVCF Ref K192901
510(k) 510(k)HealthMammo Ref K200905
510(k) 510(k)
Frequently asked questions
How many devices does Zebra Medical Vision, Ltd. have in the registry?
The registry currently lists 9 devices for Zebra Medical Vision, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zebra Medical Vision, Ltd.'s devices?
Among its 9 most recently registered devices, Zebra Medical Vision, Ltd. has devices listed in FDA 510(k) (9 devices).
What risk classes do Zebra Medical Vision, Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Zebra Medical Vision, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zebra Medical Vision, Ltd. in the registry?
The most recently registered devices listed for Zebra Medical Vision, Ltd. include HealthCCS, HealthICH, HealthPNX and HealthCXR.