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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 the device name listed in this FDA 510(k) record. The listed applicant is Huestis Machine Corporation. It received FDA 510(k) clearance on 2018-09-14 under 510(k) 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. The listed applicant is Huestis Machine Corporation. The 510(k) number is K181874.

When did MX40 Mobile Digital X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for MX40 Mobile Digital X-ray System?

The FDA 510(k) record lists Huestis Machine Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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