FDA 510(k)

X-ray Imaging System for the McLaren Proton Treatment System

Numéro K : K181498 · 2018-12-10

Date de décision2018-12-10

Code produitLHN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Ehmetdx, LLC. The 510(k) number is K181498.

When did X-ray Imaging System for the McLaren Proton Treatment System receive FDA 510(k) clearance?

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

Who is the listed applicant for X-ray Imaging System for the McLaren Proton Treatment System?

The FDA 510(k) record lists Ehmetdx, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Source officielle

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