Cleared Special

K111226 - ENDOSCOUT TRACKING SYSTEM

K111226 is an FDA 510(k) clearance for ENDOSCOUT TRACKING SYSTEM, manufactured by Robin Medical, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 60-day FDA review.

K111226 · Robin Medical, Inc. · Radiology device
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Jul 2011
Decision
60d
Days
Class 2
Risk

K111226 is an FDA 510(k) clearance for the ENDOSCOUT TRACKING SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Robin Medical, Inc. (Hudson, US). The FDA issued a Cleared decision on July 1, 2011 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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.

FDA 510(k) Submission Details - K111226

510(k) Number K111226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2011
Decision Date July 01, 2011
Days to Decision 60 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 1107
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K111226.
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K111226 · ENDOSCOUT TRACKING SYSTEM
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