Cleared Special

K102155 - MR RADIATION ONCOLOGY OPTIONS

K102155 is an FDA 510(k) clearance for MR RADIATION ONCOLOGY OPTIONS, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 32-day FDA review.

K102155 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
32d
Days
Class 2
Risk

K102155 is an FDA 510(k) clearance for the MR RADIATION ONCOLOGY OPTIONS. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 31, 2010 after a review of 32 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 - K102155

510(k) Number K102155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date August 31, 2010
Days to Decision 32 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
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 1109
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K102155.
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344 · Philips Medical Systems Nederland B.V. · Nov 2010
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
K101813 · Imris, Inc. · Oct 2010
MAGNETOM AERA
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MROPEN
K101295 · Paramed S.R.L. · Jul 2010
MRI PATIENT POSITIONING DEVICES
K093738 · Medtec, Inc. · May 2010
MR INSPIRE WITH EXTENDED KIT
K100164 · Paramed S.R.L. · Apr 2010
K102155 · MR RADIATION ONCOLOGY OPTIONS
Download PDF FDA Summary Ge Medical Systems, L…