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FDA 510(k)

VIEWRAY SYSTEM

K-Number: K111862 · 2012-05-22

ApplicantViewray, Incorporated
Decision Date2012-05-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIEWRAY 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 2012-05-22 under 510(k) number K111862. 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 VIEWRAY SYSTEM?

VIEWRAY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-22. The listed applicant is Viewray, Incorporated. The 510(k) number is K111862.

When did VIEWRAY SYSTEM receive FDA 510(k) clearance?

VIEWRAY SYSTEM received FDA 510(k) clearance on 2012-05-22, under 510(k) number K111862.

Who is the listed applicant for VIEWRAY 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 VIEWRAY SYSTEM?

The FDA product code for VIEWRAY SYSTEM is IYE.

Related Clinical Trials

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.

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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 SystemK181989MRIdian Linac SystemK170751MRIdian Linac System with 138-leaf CollimatorK162393The ViewRay (MRIdian) Linac SystemK102915VIEWRAY TREATMENT PLANNING AND DELIVERY 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.

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Official Source

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

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