Cleared Traditional

K093336 - INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM

K093336 is an FDA 510(k) clearance for INTEGRATED STIMULUS DELIVERY SYSTEM OPT..., manufactured by Medical Numerics, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K093336 · Medical Numerics, Inc. · Radiology device
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Mar 2010
Decision
130d
Days
Class 2
Risk

K093336 is an FDA 510(k) clearance for the INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Numerics, Inc. (Germantown, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 130 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 Medical Numerics, Inc. devices

FDA 510(k) Submission Details - K093336

510(k) Number K093336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2009
Decision Date March 05, 2010
Days to Decision 130 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
23d slower than avg
Panel avg: 107d · This submission: 130d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 888
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K093336.
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