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    FDA 510(k), K043557, MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS

    FDA 510(k), K043557, MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS

    $89.00 USD
    $89.00 USD
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    510(K) Number: K043557
    Device Name: MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
    Manufacturer:
    Device Classification Name: Unit, X-Ray, Extraoral With Timer
    Regulation Number: 872.1800
    Classification Product Code: EHD
    Date Received: 12/27/2004
    Decision Date: 01/13/2005
    Regulation Medical Specialty: Dental

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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