# K100233: Sudoscan

- Pathway: 510(k) (Traditional)
- Applicant: Impeto Medical
- Decided: Jun 14, 2010 after 139 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: 2 generations back to K874850 (1988). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032935: Epi-Scan, Model P 100, Edx Epi-Scan, Inc. (2003) Summary page 1.

## Most influential descendants
- K102166: Electro Interstitial Scan (2010), 2 descendants of its own
- K141872: Sudoscan (2014), 1 descendant of its own
- K131568: Sudo Path (2013), 1 descendant of its own
- K150804: QBioScan (2015), 0 descendants of its own
- K152216: SudoC (2015), 0 descendants of its own

## Indications for use
The SudoScan system is a medical device for the measurement of galvanic skin responses.

Source page: https://510kreport.com/device/K100233
Methodology: https://510kreport.com/methodology