Surgical Planning Software For Neurological Stereotaxic Instruments

QRI · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560

Classification

FDA Product Code: QRI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4560
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown