# K100468: Zeiss Infrared 800 with Flow 800 Option

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Surgical GmbH
- Decided: Mar 3, 2010 after 13 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: 6 generations back to K944261 (1994). 11 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 1.
- K080612: Leica FL800, Leica Microsystems (Schweiz) AG (2008) Summary page 1.
- K042961: Spy Intra-Operative Imaging System: SP2000, Novadaq Technologies, Inc. (2005) Summary page 1.
- K060867: Spy Intraoperative Imaging System, Novadaq Technologies, Inc. (2006) Summary page 1.
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K071037: Spy Intra-Operative Imaging System, Model SP2000, Novadaq Technologies, Inc. (2007) Summary page 1.
- K072222: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K071619: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K073088: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K202391: DIR 800 (2021), 1 descendant of its own
- K243077: Affirm 800 (2025), 0 descendants of its own
- K231986: Modus IR (2024), 0 descendants of its own
- K231075: Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (2023), 0 descendants of its own

## Indications for use
The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the 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 the 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, plastic and reconstructive procedures and coronary artery bypass graft surgery.

Source page: https://510kreport.com/device/K100468
Methodology: https://510kreport.com/methodology