Cleared Traditional

K073099 - FMRI HARDWARE SYSTEM

K073099 is an FDA 510(k) clearance for FMRI HARDWARE SYSTEM, manufactured by Nordicneurolab. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K073099 · Nordicneurolab · Radiology device
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Nov 2007
Decision
18d
Days
Class 2
Risk

K073099 is an FDA 510(k) clearance for the FMRI HARDWARE SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Nordicneurolab (Minneapolis, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 18 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 Nordicneurolab devices

FDA 510(k) Submission Details - K073099

510(k) Number K073099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2007
Decision Date November 20, 2007
Days to Decision 18 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

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All 872
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