QAF

Impedance Plethysmograph, Cranial

Product code
QAF
Device name
Impedance Plethysmograph, Cranial
Device class
Class 2
21 CFR
21 CFR 870.2770
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

Detect or measure variations in volume in the cranium, using tissue impedance properties.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-22.

NumberDecision dateApplicantDevice nameSummary
K2538402026-07-22Stroke DXSTEDI Scan DevicePDF

1 summaries are archived here for direct download.

Official FDA classification page: QAF
Classification and pathway per current FDA publications. Data from openFDA (CC0).