# K111531: RHA2020

- Pathway: 510(k) (Traditional)
- Applicant: Annidis Health Systems Corp.
- Decided: Jul 8, 2011 after 36 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- 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: 2 generations back to K871268 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983999: PANORAMIC200 Opthalmoscope, Optos Plc. (1999) Summary page 1.
- K072259: Ophthalmoscope F-10, Nidek Co., Ltd. (2008) Summary page 1.
- K092056: Optomed Smartscope, Model M3-1 EY1, Optomed OY (2009) Summary page 3.

## Indications for use
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Source page: https://510kreport.com/device/K111531
Methodology: https://510kreport.com/methodology