# K062578: Digi-Lite TCD Device

- Pathway: 510(k) (Special)
- Applicant: Rimed, Ltd.
- Decided: Sep 18, 2006 after 18 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: 1 generation back to K974588 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974588: Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral Transcranial Doppler Device, Compact Mod, Rimed, Ltd. (1998) Summary page 2.

## Most influential descendants
- K143476: Digi-One (2015), 0 descendants of its own

## Indications for use
The Digi-Lite Trans Cranial and Vascular Doppler (TCD) is intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

Source page: https://510kreport.com/device/K062578
Methodology: https://510kreport.com/methodology