# K130003: Xiralite Flourescence Imaging System X4

- Pathway: 510(k) (Traditional)
- Applicant: Mivenion GmbH
- Decided: Jan 31, 2014 after 394 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 2.
- K073088: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 2.

## Indications for use
Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.

Source page: https://510kreport.com/device/K130003
Methodology: https://510kreport.com/methodology