Cleared Traditional

K100836 - CLEARPOINT SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100836 · Surgivision, Inc. · Radiology device
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Jun 2010
Decision
84d
Days
Class 2
Risk

K100836 is an FDA 510(k) clearance for the CLEARPOINT SYSTEM. Classified as Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (product code ORR), Class II - Special Controls.

Submitted by Surgivision, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on June 16, 2010 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.4560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgivision, Inc. devices

Submission Details

510(k) Number K100836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2010
Decision Date June 16, 2010
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORR Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.