# K231075: Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jun 20, 2023 after 67 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162991: YELLOW 560 Fluorescence Module, Carl Zeiss Meditec, AG (2017) Summary page 5.
- K100468: Zeiss Infrared 800 with Flow 800 Option, Carl Zeiss Surgical GmbH (2010) Summary page 5.

## Indications for use
INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery. YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Source page: https://510kreport.com/device/K231075
Methodology: https://510kreport.com/methodology