Cleared Traditional

K962606 - TOPOGRAPHIC IMAGING MARKER

K962606 is an FDA 510(k) clearance for TOPOGRAPHIC IMAGING MARKER, manufactured by I.Z.I. Medical Products Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K962606 · I.Z.I. Medical Products Corp. · Radiology device
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Aug 1996
Decision
36d
Days
Class 2
Risk

K962606 is an FDA 510(k) clearance for the TOPOGRAPHIC IMAGING MARKER. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by I.Z.I. Medical Products Corp. (Owings Mills, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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. Medical Products Corp. devices

FDA 510(k) Submission Details - K962606

510(k) Number K962606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1996
Decision Date August 07, 1996
Days to Decision 36 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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 162
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K962606.
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