HealthCXR
K-Number: K192320 · 2019-11-26
ApplicantZebra Medical Vision, Ltd.
Decision Date2019-11-26
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HealthCXR is a medical device manufactured by Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192320. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HealthCXR?
HealthCXR is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Zebra Medical Vision, Ltd.. The 510(k) number is K192320.
When was HealthCXR approved by the FDA?
HealthCXR received FDA 510(k) clearance on 2019-11-26, under approval number K192320.
What company makes HealthCXR?
HealthCXR is manufactured by Zebra Medical Vision, Ltd..
What is the FDA product code for HealthCXR?
The FDA product code for HealthCXR is QFM.
Other Devices by Zebra Medical Vision, Ltd.
Related Devices (Code: QFM)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.