# K182967: Visor System

- Pathway: 510(k) (Special)
- Applicant: Cerebrotech Medical Systems, Inc.
- Decided: Nov 23, 2018 after 28 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: 6 generations back to K904109 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171186: Cerebrotech CMS-5000, Cerebrotech Medical Systems (2017) Summary page 4.

## Most influential descendants
- K253840: STEDI Scan Device (2026), 0 descendants of its own

## Indications for use
The Visor System 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 neurologic assessment. The Visor System is an adjunct to standard methodologies for clinical evaluation.

Source page: https://510kreport.com/device/K182967
Methodology: https://510kreport.com/methodology