# K061871: Leica Model FL800

- Pathway: 510(k) (Traditional)
- Applicant: Leica Microsystems, Inc.
- Decided: Sep 20, 2006 after 79 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: 2 generations back to K944261 (1994). 3 ancestors in all.
133 later devices descend from it; 10 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042961: Spy Intra-Operative Imaging System: SP2000, Novadaq Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K063345: Spy Imaging System (2007), 131 descendants of its own
- K072222: Spy Fluorescent Imaging System (2007), 129 descendants of its own
- K073088: Spy Fluorescent Imaging System (2008), 119 descendants of its own
- K091515: Spy Scope Intra-Operative Operating System (2009), 106 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own

## Indications for use
The Leica FL800 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.

Source page: https://510kreport.com/device/K061871
Methodology: https://510kreport.com/methodology