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FDA 510(k)

UC-5000 Mobile X-Ray

K-Number: K163063 · 2016-12-12

ApplicantSource-Ray, Inc.
Decision Date2016-12-12
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UC-5000 Mobile X-Ray is a medical device manufactured by Source-Ray, Inc.. It received FDA 510(k) clearance on 2016-12-12 under approval number K163063. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UC-5000 Mobile X-Ray?

UC-5000 Mobile X-Ray is a medical device that received FDA 510(k) clearance on 2016-12-12. It is manufactured by Source-Ray, Inc.. The 510(k) number is K163063.

When was UC-5000 Mobile X-Ray approved by the FDA?

UC-5000 Mobile X-Ray received FDA 510(k) clearance on 2016-12-12, under approval number K163063.

What company makes UC-5000 Mobile X-Ray?

UC-5000 Mobile X-Ray is manufactured by Source-Ray, Inc..

What is the FDA product code for UC-5000 Mobile X-Ray?

The FDA product code for UC-5000 Mobile X-Ray is IZL.

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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.

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