Cleared Traditional

YELLOW 560 Fluorescence Module

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

About This 510(k) Submission

K162991 is an FDA 510(k) clearance for the YELLOW 560 Fluorescence Module, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on July 24, 2017, 270 days after receiving the submission on October 27, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K162991 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — IZI System, X-ray, Angiographic

All 196
IC-Flow? Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Modus IR
K231986 · Synaptive Medical, Inc. · Mar 2024
EXPLORER AIR? II (8001, 8002, 8003); EXPLORER AIR? Sterile Drape (8004)
K234090 · Surgvision GmbH · Mar 2024
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · Novadaq Technologies Ulc (A Part of Stryker) · Jun 2023