iFusion User’s Manual 8 P/N 580-48483-004 Rev B
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.
Intended Use
iCam Fundus Camera (K122572) – The iCam is a non-
contact, high resolution digital imaging device which is
suitable for photographing, displaying and storing images of
the retina and external areas of the eye to be evaluated
under non-mydriatic conditions. The iCam takes digital
images of the posterior and external structures of the eye
without the use of a mydriatic agent and is intended for use
as an aid to clinicians in the evaluation, diagnosis and
documentation of ocular health. iCam provides images only
and does not provide any diagnostic, pathological analysis or
classification of ocular health or disease.
AND
iVue 100 with Normative Database (K121739) – The iVue is
a non-contact, high resolution optical coherence tomography
system intended for in vivo imaging, axial cross-sectional,
three dimensional imaging and measurement of anterior and
posterior ocular structures, including retina, retinal nerve
fiber layer, ganglion cell complex (GCC), optic disc, cornea,
and anterior chamber of the eye. The iVue with Normative
Database is a quantitative tool for comparison of retina,
retinal nerve fiber layer, ganglion cell complex, and optic disc
measurements to a database of known normal subjects.
