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Surgical Planning Software For Neurological Stereotaxic Instruments

FDA product code QRI · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-08 – 2023-09-08

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.

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