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510(k) Data Aggregation
K Number
K181874Device Name
MX40 Mobile Digital X-ray System
Manufacturer
Huestis Machine Corporation
Date Cleared
2018-09-14
(63 days)
Product Code
IZL, MOB
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Huestis Machine Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Device Description
The MX40 is comprised of a High Voltage Generator with a maximum power output of 50 kW, the MX40 can meet different exposure needs for varying positions and body mass. With the MX40's state-of-the-art design and powerful 50 kW generator coupled with the Varex PaxScan digital flat panel image receptor and E-COM Digital Radiography Operator Console (used on previously cleared devices K130883 and K143232), users can obtain clearer images quickly and easily. Our latest mobile X-ray system is based on the revolutionary MX family.
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