FDA 510(k), K181704, Transpara

FDA 510(k), K181704, Transpara

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510(K) Number: K181704
Device Name: Transpara
Manufacturer: Nico Karssemeijer
Device Classification Name: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation Number: QDQ
Classification Product Code: KXA
Date Received: 06/27/2018
Decision Date: 11/21/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

Total pages: 2,213  
Fully redacted pages: 1,638  
Content pages: 575 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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