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U.S. Department of Health and Human Services

Product Classification
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Device surgical planning software for neurological stereotaxic instruments
Regulation Description Stereotaxic instrument.
Definition A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries.
Physical State Software
Technical Method Performs an analysis of patient radiographic anatomical images for the creation of navigation plans in neurosurgical stereotactic or image-guided procedures.
Target Area Intracranial
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQRI
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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