Cleared Traditional

K121997 - IMRIS ONCOLOGY PACKAGE

K121997 is an FDA 510(k) clearance for IMRIS ONCOLOGY PACKAGE, manufactured by Imris, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K121997 · Imris, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
32d
Days
Class 2
Risk

K121997 is an FDA 510(k) clearance for the IMRIS ONCOLOGY PACKAGE. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Imris, Inc. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on August 10, 2012 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imris, Inc. devices

FDA 510(k) Submission Details - K121997

510(k) Number K121997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date August 10, 2012
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
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 872
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K121997.
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G-SCAN BRIO
K122006 · Esaote, S.P.A. · Aug 2012
MAGNETOM SPECTRA
K121160 · Siemens Medical Solutions USA, Inc. · Jul 2012
S-SCAN
K121650 · Esaote, S.P.A. · Jul 2012