Cleared Traditional

K170239 - Leica FL560

K170239 is an FDA 510(k) clearance for Leica FL560, manufactured by Leica Microsystems (Schweiz) AG. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K170239 · Leica Microsystems (Schweiz) AG · Radiology device
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Jul 2017
Decision
160d
Days
Class 2
Risk

K170239 is an FDA 510(k) clearance for the Leica FL560. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Leica Microsystems (Schweiz) AG (Heerbrugg, CH). The FDA issued a Cleared decision on July 5, 2017 after a review of 160 days - an extended review 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: 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 Leica Microsystems (Schweiz) AG devices

FDA 510(k) Submission Details - K170239

510(k) Number K170239 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 26, 2017
Decision Date July 05, 2017
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
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.

Regulatory Peers - IZI System, X-ray, Angiographic

All 149
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