The ViewRay (MRIdian) Linac System— 510(k) K162393

Name: FDA 510(k) clearance K162393
Creator: U.S. Food and Drug Administration
Published: 2017-02-24

Substantially Equivalent

Viewray, Incorporated

FDA 510(k) clearance K162393 for The ViewRay (MRIdian) Linac System, Substantially Equivalent on 2017-02-24. Applicant: Viewray, Incorporated. Device class: 2.

Clearance details

Applicant: Viewray, Incorporated
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-08-26
Decision date: 2017-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Viewray, Incorporated

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K212958 — MRIdian Linac System2021-12-14
K181989 — MRIdian Linac System2019-02-20
K170751 — MRIdian Linac System with 138-leaf Collimator2017-06-07
K111862 — VIEWRAY SYSTEM2012-05-22
K102915 — VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM2011-01-12

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.