FDA 510(k) K162393, The ViewRay (MRIdian) Linac System, by Viewray, Incorporated

FDA 510(k) K162393, The ViewRay (MRIdian) Linac System, by Viewray, Incorporated

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Device Classification Name: Accelerator, Linear, Medical
510(k) Number: K162393
Device Name: The ViewRay (MRIdian) Linac System
Applicant: Viewray, Incorporated
Regulation Number: 892.505
Classification Product Code: IYE
Date Received: 08/26/2016
Decision Date: 02/24/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology

Total number of pages: 54
Fully redacted pages: 15
Content pages: 39

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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