# K192761: Asimov-MKS Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Onlume, Inc.
- Decided: Jan 17, 2020 after 109 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: 8 generations back to K944261 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182907: SPY Elite Intraoperative Perfusion Assessment System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2019) Summary page 4.

## Indications for use
The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.

Source page: https://510kreport.com/device/K192761
Methodology: https://510kreport.com/methodology