# K253840: STEDI Scan Device

- Pathway: 510(k) (Traditional)
- Applicant: Stroke DX
- Decided: Jul 22, 2026 after 233 days
- Product code: QAF (Impedance Plethysmograph, Cranial)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904109 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182967: Visor System, Cerebrotech Medical Systems, Inc. (2018) Summary page 6.

## Indications for use
The STEDI Scan Device is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurological assessment The STEDI Scan Device is an adjunct to standard methodologies for clinical evaluation

Source page: https://510kreport.com/device/K253840
Methodology: https://510kreport.com/methodology