FDA 510(K) K180995, Vscan Extend

FDA 510(K) K180995, Vscan Extend

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Device Classification Name    System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number    K180995
Device Name    Vscan Extend
Applicant    GE Medical Systems Ultrasound and Primary Care Diagnostics
Regulation Number    892.1550
Classification Product Code    IYN  
Subsequent Product Codes    ITX      IYO  
Date Received    04/16/2018
Decision Date    06/25/2018
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Radiology

Total pages: 1422
Fully redacted pages: 1196
Content pages: 226

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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