# K003236: Retinadx

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Associates, Inc.
- Decided: Nov 2, 2000 after 16 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan. The RetinaDx system can be used with any patient of any age or condition who is able to sit still enough to have the photographs taken.

Source page: https://510kreport.com/device/K003236
Methodology: https://510kreport.com/methodology