# K070231: ORION

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Technologies Srl
- Decided: Apr 24, 2007 after 90 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941234 (1995). 6 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023719: MP-1 Micro Perimeter, Nidek Technologies Srl (2002) Summary page 2.
- K061768: MP-1 Microperimeter, Nidek Technologies Srl (2006) Summary page 2.
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000, Nidek, Inc. (2002) Summary page 2.

## Most influential descendants
- K101935: Centervue Digital Retinography System (2010), 21 descendants of its own
- K142047: EIDON (2014), 8 descendants of its own
- K122572: Icam Fundus Camera (2013), 8 descendants of its own
- K182199: NFC-700 non-mydriatic auto fundus camera (2019), 3 descendants of its own
- K180526: Eidon FA (2018), 2 descendants of its own

## Indications for use
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.

Source page: https://510kreport.com/device/K070231
Methodology: https://510kreport.com/methodology