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FDA 510(k)

MRIdian Linac System

K-Number: K181989 · 2019-02-20

ApplicantViewray, Incorporated
Decision Date2019-02-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRIdian Linac System is the device name listed in this FDA 510(k) record. The listed applicant is Viewray, Incorporated. It received FDA 510(k) clearance on 2019-02-20 under 510(k) number K181989. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRIdian Linac System?

MRIdian Linac System is a medical device that received FDA 510(k) clearance on 2019-02-20. The listed applicant is Viewray, Incorporated. The 510(k) number is K181989.

When did MRIdian Linac System receive FDA 510(k) clearance?

MRIdian Linac System received FDA 510(k) clearance on 2019-02-20, under 510(k) number K181989.

Who is the listed applicant for MRIdian Linac System?

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

What is the FDA product code for MRIdian Linac System?

The FDA product code for MRIdian Linac System is IYE.

Other records listing Viewray, Incorporated as applicant

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.

K212958MRIdian Linac SystemK170751MRIdian Linac System with 138-leaf CollimatorK162393The ViewRay (MRIdian) Linac System

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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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