X-ray Imaging System for the McLaren Proton Treatment System— 510(k) K181498

Name: FDA 510(k) clearance K181498
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Substantially Equivalent

Ehmetdx, LLC

FDA 510(k) clearance K181498 for X-ray Imaging System for the McLaren Proton Treatment System, Substantially Equivalent on 2018-12-10. Applicant: Ehmetdx, LLC. Device class: 2.

Clearance details

Applicant: Ehmetdx, LLC
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2018-06-07
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MI, US

Download summary PDF View on FDA.gov ↗

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