Cleared Traditional

PIXELL MRI SYSTEM (K962249) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962249 · General Medical Equipment Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
213d
Days
Class 2
Risk

K962249 is an FDA 510(k) clearance for the PIXELL MRI SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by General Medical Equipment Corp. (Sound Beach, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 213 days - an extended review cycle.

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 General Medical Equipment Corp. devices

Submission Details

510(k) Number K962249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1996
Decision Date January 10, 1997
Days to Decision 213 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
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K962249.
KINEMATIC POSITIONING DEVICES
K964752 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · General Electric Co. · Jan 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370 · GE Medical Systems · Jan 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K962061 · GE Medical Systems · Nov 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963429 · GE Medical Systems · Nov 1996