# K231986: Modus IR

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Mar 25, 2024 after 264 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: 7 generations back to K944261 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100468: Zeiss Infrared 800 with Flow 800 Option, Carl Zeiss Surgical GmbH (2010) Summary page 6.

## Indications for use
Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

Source page: https://510kreport.com/device/K231986
Methodology: https://510kreport.com/methodology