# K150804: QBioScan

- Pathway: 510(k) (Traditional)
- Applicant: Medeia, Inc.
- Decided: Oct 19, 2015 after 207 days
- Product code: GZO (Device, Galvanic Skin Response Measurement)
- Device class: 2
- Regulation: 21 CFR 882.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K874850 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100233: Sudoscan, Impeto Medical (2010) Summary page 4.
- K141872: Sudoscan, Impeto Medical, Inc. (2014) Summary page 4.

## Indications for use
QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function. The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.

Source page: https://510kreport.com/device/K150804
Methodology: https://510kreport.com/methodology