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FDA 510(k)

X-ray Imaging System for the McLaren Proton Treatment System

K-Number: K181498 · 2018-12-10

ApplicantEhmetdx, LLC
Decision Date2018-12-10
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-ray Imaging System for the McLaren Proton Treatment System is a medical device manufactured by Ehmetdx, LLC. It received FDA 510(k) clearance on 2018-12-10 under approval number K181498. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-ray Imaging System for the McLaren Proton Treatment System?

X-ray Imaging System for the McLaren Proton Treatment System is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Ehmetdx, LLC. The 510(k) number is K181498.

When was X-ray Imaging System for the McLaren Proton Treatment System approved by the FDA?

X-ray Imaging System for the McLaren Proton Treatment System received FDA 510(k) clearance on 2018-12-10, under approval number K181498.

What company makes X-ray Imaging System for the McLaren Proton Treatment System?

X-ray Imaging System for the McLaren Proton Treatment System is manufactured by Ehmetdx, LLC.

What is the FDA product code for X-ray Imaging System for the McLaren Proton Treatment System?

The FDA product code for X-ray Imaging System for the McLaren Proton Treatment System is LHN.

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Official Source

View on FDA Database →

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

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