DeviceClearance

MX40 Mobile Digital X-ray System— 510(k) K181874

Substantially Equivalent

Huestis Machine Corporation

FDA 510(k) clearance K181874 for MX40 Mobile Digital X-ray System, Substantially Equivalent on 2018-09-14. Applicant: Huestis Machine Corporation. Device class: 2.

Clearance details

Applicant
Huestis Machine Corporation
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bristol, RI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IZL

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.