# K984307: Modification of: Rheo Dopplex II

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Jan 12, 1999 after 41 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
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. The FDA summary names no predicate by number.

## Indications for use
Venous photoplethysmography and bi-directional Doppler for venous and arterial assessment, and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.

Source page: https://510kreport.com/device/K984307
Methodology: https://510kreport.com/methodology