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Surgical Planning Software For Neurological Stereotaxic Instruments

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

Surgical Planning Software For Neurological Stereotaxic Instruments

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).