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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 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.

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. 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.

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

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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