Cleared Special

K113228 - RENAISSANCE SYSTEM

K113228 is an FDA 510(k) clearance for RENAISSANCE SYSTEM, manufactured by Mazor Robotics , Ltd.. The device is a Class 2 Radiology device with product code HAW cleared through the Special 510(k) pathway after a 30-day FDA review.

K113228 · Mazor Robotics , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
30d
Days
Class 2
Risk

K113228 is an FDA 510(k) clearance for the RENAISSANCE SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Mazor Robotics , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on December 1, 2011 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mazor Robotics , Ltd. devices

FDA 510(k) Submission Details - K113228

510(k) Number K113228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2011
Decision Date December 01, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 243
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