FDA 510(k), K061916, NEURO II-SE, MODELS OR-MB-DR AND OR-DR
FDA 510(k), K061916, NEURO II-SE, MODELS OR-MB-DR AND OR-DR
510(K) Number: K061916
Device Name: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Manufacturer: IMRIS, INC.
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 07/06/2006
Decision Date: 08/11/2006
Regulation Medical Specialty: Radiology
Total pages: 511
Fully redacted pages: 199
Content pages: 312
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details