Cleared Traditional

K003736 - MRI LINE MARKER

K003736 is an FDA 510(k) clearance for MRI LINE MARKER, manufactured by I.Z.I. Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K003736 · I.Z.I. Corp. · Radiology device
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Jan 2001
Decision
45d
Days
Class 2
Risk

K003736 is an FDA 510(k) clearance for the MRI LINE MARKER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by I.Z.I. Corp. (Owings Mills, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 I.Z.I. Corp. devices

FDA 510(k) Submission Details - K003736

510(k) Number K003736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date January 18, 2001
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 673
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K003736.
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V SCORE WITH AUTO GATE MODEL TBD
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CT CORD IQ OPTION 1.0
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SOMATOM SMILE
K003152 · Siemens Medical Solutions USA, Inc. · Oct 2000