FDA 510(k), K163328, Planmed Clarity

FDA 510(k), K163328, Planmed Clarity

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510(K) Number: K163328
Device Name: Planmed Clarity
Manufacturer: Lars Moring
Device Classification Name: Full Field Digital, System, X-Ray, Mammographic
Regulation Number: MUE
Classification Product Code: KXA
Date Received: 11/28/2016
Decision Date: 12/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

Total pages: 4,500
Fully redacted pages: 4,020
Content pages: 480

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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