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FDA 510(k)

MobileX Portable X-ray System

K-Number: K180561 · 2018-04-04

ApplicantDenterprise International, Inc.
Decision Date2018-04-04
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MobileX Portable X-ray System is a medical device manufactured by Denterprise International, Inc.. It received FDA 510(k) clearance on 2018-04-04 under approval number K180561. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MobileX Portable X-ray System?

MobileX Portable X-ray System is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Denterprise International, Inc.. The 510(k) number is K180561.

When was MobileX Portable X-ray System approved by the FDA?

MobileX Portable X-ray System received FDA 510(k) clearance on 2018-04-04, under approval number K180561.

What company makes MobileX Portable X-ray System?

MobileX Portable X-ray System is manufactured by Denterprise International, Inc..

What is the FDA product code for MobileX Portable X-ray System?

The FDA product code for MobileX Portable X-ray System is EHD.

Related Clinical Trials

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Other Devices by Denterprise International, Inc.

K231202QuickRayPRO

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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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