# K072259: Ophthalmoscope F-10

- Pathway: 510(k) (Abbreviated)
- Applicant: Nidek Co., Ltd.
- Decided: May 6, 2008 after 266 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- 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: 1 generation back to K871268 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C), Heidelberg Engineering (1997) Summary page 1.
- K871268: Rodenstock Scanning Laser Ophthalmoscope, G. Rodenstock Instrumente GmbH (1987) Summary page 1.

## Most influential descendants
- K111531: RHA2020 (2011), 0 descendants of its own

## Indications for use
The Ophthalmoscope F-10 is intended for use in capturing images of the fundus, which can be used for the diagnosis of fundus diseases.

Source page: https://510kreport.com/device/K072259
Methodology: https://510kreport.com/methodology