Cleared Traditional

K061871 - LEICA MODEL FL800

K061871 is an FDA 510(k) clearance for LEICA MODEL FL800, manufactured by Leica Microsystems, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K061871 · Leica Microsystems, Inc. · Radiology device
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Sep 2006
Decision
79d
Days
Class 2
Risk

K061871 is an FDA 510(k) clearance for the LEICA MODEL FL800. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Leica Microsystems, Inc. (Park City, US). The FDA issued a Cleared decision on September 20, 2006 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Leica Microsystems, Inc. devices

FDA 510(k) Submission Details - K061871

510(k) Number K061871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date September 20, 2006
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 144
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