# K122376: PMT Truscan Surface Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: Dec 19, 2012 after 135 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032278 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode, Ambu, Inc. (2004)
- (no number) Grass Instruments: named in the summary without a submission number

## Most influential descendants
- K171102: Ives MR Conditional Cup Electrode (2017), 0 descendants of its own

## Indications for use
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP). The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions: Static magnetic field strength of 1.5-T only Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times. The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan. Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

Source page: https://510kreport.com/device/K122376
Methodology: https://510kreport.com/methodology