# K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Mar 30, 2023 after 328 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K012727 (2002). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180660: Avanti, Optovue, Inc. (2018) Summary page 4.
- K142897: P200DTx, Optos Plc. (2015) Summary page 4.
- K181345: Image Filing Software NAVIS-EX, Nidek Co., Ltd. (2018) Summary page 4.

## Indications for use
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: • the retina, retinal nerve fiber layer, optic disc, and • the anterior chamber and cornea (when used with the optional anterior segment OCT adapter) and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices. Scanning Laser Ophthalmoscope Mirante [SLO Model] The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Source page: https://510kreport.com/device/K221320
Methodology: https://510kreport.com/methodology