Cleared Traditional

MUSCLE IMAGING SYSTEM (MIS) (K011416) - FDA 510(k) Clearance

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

K011416 · Millennium Magnetic Imaging, Inc. · Radiology device
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Aug 2001
Decision
90d
Days
Class 2
Risk

K011416 is an FDA 510(k) clearance for the MUSCLE IMAGING SYSTEM (MIS). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Millennium Magnetic Imaging, Inc. (Hoover, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 90 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 Millennium Magnetic Imaging, Inc. devices

Submission Details

510(k) Number K011416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date August 06, 2001
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K011416.
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
GE SIGNA ASSET IMAGING OPTION
K012970 · GE Medical Systems · Sep 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · GE Medical Systems · Aug 2001
INFINION ENHANCEMENT PACKAGE
K011296 · Philips Medical Systems (Cleveland), Inc. · Jul 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · Siemens Medical Solutions USA, Inc. · May 2001