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FDA 510(k)

MX40 Mobile Digital X-ray System

K-Number: K181874 · 2018-09-14

ApplicantHuestis Machine Corporation
Decision Date2018-09-14
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MX40 Mobile Digital X-ray System is a medical device manufactured by Huestis Machine Corporation. It received FDA 510(k) clearance on 2018-09-14 under approval number K181874. 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 MX40 Mobile Digital X-ray System?

MX40 Mobile Digital X-ray System is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Huestis Machine Corporation. The 510(k) number is K181874.

When was MX40 Mobile Digital X-ray System approved by the FDA?

MX40 Mobile Digital X-ray System received FDA 510(k) clearance on 2018-09-14, under approval number K181874.

What company makes MX40 Mobile Digital X-ray System?

MX40 Mobile Digital X-ray System is manufactured by Huestis Machine Corporation.

What is the FDA product code for MX40 Mobile Digital X-ray System?

The FDA product code for MX40 Mobile Digital X-ray System is IZL.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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