# K243645: IC-Flow™ Imaging System 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Green GmbH
- Decided: Sep 22, 2025 after 300 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: 21 generations back to K930667 (1994). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System, Novadaq Technologies Ulc (A Part of Stryker) (2023) Summary page 6.
- K133719: Pde-Neo, Hamamatsu Photonics K.K. (2014) Summary page 6.

## Indications for use
IC-Flow™ Imaging System 2.0, used in conjunction with Indocyanine Green (ICG), is indicated for fluorescence imaging of blood flow, tissue perfusion, and the lymphatic system in both adult and pediatric patients one month of age and older. Upon intravenous administration of ICG, the IC-Flow™ Imaging System 2.0 is used for fluorescence angiography before and after vascular, and plastic, micro-, and reconstructive procedures. Additionally, upon subcutaneous administration, the system is used for fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels.

Source page: https://510kreport.com/device/K243645
Methodology: https://510kreport.com/methodology