FDA 510(K) K211034, Corvus Radiation Therapy Planning System

FDA 510(K) K211034, Corvus Radiation Therapy Planning System

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Device Classification Name    System, Planning, Radiation Therapy Treatment
510(k) Number    K211034
Device Name    Corvus Radiation Therapy Planning System
Applicant    Best Nomos
Regulation Number    892.5050
Classification Product Code    MUJ  
Date Received    04/07/2021
Decision Date    05/06/2021
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Radiology

Total pages: 437
Fully redacted pages: 133
Content pages: 304

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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