YELLOW 560 Fluorescence Module— 510(k) K162991

Clearance details

Applicant

Carl Zeiss Meditec, AG

Product code

Code IZI

Device class

Class 2

Regulation

21 CFR 892.1600

Advisory panel

Radiology

Date received

2016-10-27

Decision date

2017-07-24

Decision

Unknown

Clearance type

Traditional

Location

Jena, DE

• K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
• K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
• K243645 — IC-Flow Imaging System 2.02025-09-22
• K243077 — Affirm 8002025-06-27
• K231986 — Modus IR2024-03-25

• K260694 — ZEISS CLINIC 3602026-07-17
• K241174 — INTRABEAM (700) +1 more2025-01-10
• K233911 — VISULAS combi2024-09-06
• K240215 — BLUE 400; BLUE 400 S2024-06-28
• K233421 — RESCAN 7002024-03-08

Death

9

Malfunction

5,312

Total

5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →