Cleared Traditional

K162991 - YELLOW 560 Fluorescence Module (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162991 · Carl Zeiss Meditec, AG · Radiology device
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Jul 2017
Decision
270d
Days
Class 2
Risk

K162991 is an FDA 510(k) clearance for the YELLOW 560 Fluorescence Module. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on July 24, 2017 after a review of 270 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 Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K162991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 27, 2016
Decision Date July 24, 2017
Days to Decision 270 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
163d slower than avg
Panel avg: 107d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 196
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