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FDA 510(k) K202546, LVivo Seamless, by Dia Imaging Analysis, Ltd.

FDA 510(k) K202546, LVivo Seamless, by Dia Imaging Analysis, Ltd.

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510(K) Number: K202546
Device Name: LVivo Seamless
Manufacturer: Dia Imaging Analysis, Ltd.
Device Classification Name: Automated Radiological Image Processing Software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 09/02/2020
Decision Date: 09/29/2020
Regulation Medical Specialty: Radiology

125 pages (134 of 259 pages fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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