FDA 510(k) K191332, XACT Robotic System, by Xact Robotics, Ltd.

FDA 510(k) K191332, XACT Robotic System, by Xact Robotics, Ltd.

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Device Classification Name: System, X-Ray, Tomography, Computed
510(k) Number: K191332
Device Name: XACT Robotic System
Applicant: Xact Robotics, Ltd.
Regulation Number: 892.175
Classification Product Code: JAK
Date Received: 2019-05-16
Decision Date: 2019-10-03
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology

Total number of pages: 2,207
Fully redacted pages: 1,942
Content pages: 265

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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