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

Substantially Equivalent

Viewray, Incorporated

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

Clearance details

Applicant: Viewray, Incorporated
Product code: Code IYE
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 ↗

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.