JADE Mobile X-Ray
K-Number: K183388 · 2019-02-05
ApplicantDRGEM Corporation
Decision Date2019-02-05
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
JADE Mobile X-Ray is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2019-02-05 under approval number K183388. 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 JADE Mobile X-Ray?
JADE Mobile X-Ray is a medical device that received FDA 510(k) clearance on 2019-02-05. It is manufactured by DRGEM Corporation. The 510(k) number is K183388.
When was JADE Mobile X-Ray approved by the FDA?
JADE Mobile X-Ray received FDA 510(k) clearance on 2019-02-05, under approval number K183388.
What company makes JADE Mobile X-Ray?
JADE Mobile X-Ray is manufactured by DRGEM Corporation.
What is the FDA product code for JADE Mobile X-Ray?
The FDA product code for JADE 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.