# K143476: Digi-One

- Pathway: 510(k) (Special)
- Applicant: Rimed, Ltd.
- Decided: Jun 23, 2015 after 200 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K974588 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062578: Digi-Lite TCD Device, Rimed, Ltd. (2006) Summary page 9.

## Indications for use
The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adult and in children. It is not intended for fetal use. It is not intended for neonatal use.

Source page: https://510kreport.com/device/K143476
Methodology: https://510kreport.com/methodology