# K130656: Ifusion

- Pathway: 510(k) (Special)
- Applicant: Optovue, Inc.
- Decided: Jul 3, 2013 after 113 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941234 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121739: Ivue with Normative Database, Optovue, Inc. (2013) Summary page 1.
- K122572: Icam Fundus Camera, Optovue, Inc. (2013) Summary page 1.

## Recalls of this device
- Jul 27, 2017 · Class II · Z-0009-2018: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

## Indications for use
The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use. The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.

Source page: https://510kreport.com/device/K130656
Methodology: https://510kreport.com/methodology