# K253181: SURGIMAGE SIM 1000H Fluorescence Imaging Platform

- Pathway: 510(k) (Traditional)
- Applicant: Surgimage Corporation
- Decided: May 13, 2026 after 229 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 5.

## Indications for use
SURGIMAGE SIM 1000H Fluorescence Imaging Platform: Upon intravenous administration and use of ICG (Indocyanine Green) consistent with its approved label, the SIM 1000H System is used with ICG(Indocyanine Green) to perform intraoperative fluorescence angiography. The SIM 1000H System is indicated for use in adult. The SIM 1000H System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures. Upon interstitial administration and use of ICG (Indocyanine Green) consistent with its approved label, the SIM 1000H System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon intradermal administration and use of ICG (Indocyanine Green) consistent with its approved label, the SIM 1000H System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.

Source page: https://510kreport.com/device/K253181
Methodology: https://510kreport.com/methodology