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FDA 510(k) K001781, CURRY MULTIMODAL NEUROIMAGING SOFTWARE, by Neurosoft, Inc.

FDA 510(k) K001781, CURRY MULTIMODAL NEUROIMAGING SOFTWARE, by Neurosoft, Inc.

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FDA 510(k) records for CURRY MULTIMODAL NEUROIMAGING SOFTWARE (K001781), submitted by Neurosoft, Inc..

  • 510(k) Number: K001781
  • Applicant: Neurosoft, Inc.
  • Decision Date: 02/05/2001
  • Decision: Substantially Equivalent (SESE)
  • Product Code: OLX OLX
  • Review Panel: Neurology
  • Total PDF Pages: 546
  • Fully Redacted Pages: 438
  • Usable Pages: 108

Sections Included

  • Entire Document: pages 1-546; 80.2% redacted (Heavy Redaction)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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