Cleared Traditional

K072473 - CHASE MR SYSTEM

K072473 is an FDA 510(k) clearance for CHASE MR SYSTEM, manufactured by Chase Medical, LP. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K072473 · Chase Medical, LP · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
97d
Days
Class 2
Risk

K072473 is an FDA 510(k) clearance for the CHASE MR SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Chase Medical, LP (Richardson, US). The FDA issued a Cleared decision on December 10, 2007 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chase Medical, LP devices

FDA 510(k) Submission Details - K072473

510(k) Number K072473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date December 10, 2007
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 901
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K072473.
QPLAQUE MR
K073156 · Medis Medical Imaging Systems BV · Mar 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · Toshiba America Medical Systems, In.C · Jan 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167 · Ge Medical Systems, LLC · Jan 2008
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081 · Toshiba America Medical Systems, In.C · Nov 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998 · Ge Medical Systems, LLC · Nov 2007
MAGNETOM VERIO
K072237 · Siemens Medical Solutions USA, Inc. · Oct 2007