Cleared Special

K013150 - MR-GUIDE 2000

K013150 is an FDA 510(k) clearance for MR-GUIDE 2000, manufactured by Ultraguide , Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 28-day FDA review.

K013150 · Ultraguide , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
28d
Days
Class 2
Risk

K013150 is an FDA 510(k) clearance for the MR-GUIDE 2000. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ultraguide , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on October 18, 2001 after a review of 28 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 - K013150

510(k) Number K013150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date October 18, 2001
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 1102
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K013150.
INTERA I/T
K013344 · Philips Medical Systems North America Co. · Dec 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · GE Medical Systems · Nov 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · Siemens Medical Solutions USA, Inc. · Oct 2001
NUMARIS 4VA15A
K012202 · Siemens Medical Corp. · Sep 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · GE Medical Systems · Sep 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · Aurora Imaging Technology, Inc. · Sep 2001
K013150 · MR-GUIDE 2000
Download PDF FDA Summary Ultraguide , Ltd.