Cleared Traditional

K162991 - YELLOW 560 Fluorescence Module

K162991 is an FDA 510(k) clearance for YELLOW 560 Fluorescence Module, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K162991 · Carl Zeiss Meditec, AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162991

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
PCCP Authorized No
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.

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 Consultant

Carl Zeiss Meditec, Inc.
Mandy Ambrecht

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZI System, X-ray, Angiographic

All 162
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K162991.
SPY Elite Intraoperative Perfusion Assessment System
K182907 · Novadaq Technologies Ulc. (Now A Part of Stryker) · Jan 2019
GLOW800
K181537 · Leica Microsystems (Schweiz) AG · Sep 2018
CAAS Workstation
K180019 · Pie Medical Imaging BV · May 2018
Leica FL560
K170239 · Leica Microsystems (Schweiz) AG · Jul 2017
CAAS Workstation
K151780 · Pie Medical Imaging BV · Mar 2016
LEICA FL800
K141136 · Leica Biosystems Richmond · Aug 2014