# K161027: Cadwell AmpliScan

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Nov 8, 2016 after 210 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K132306 (2013). 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)
- K132306: Persyst 12 Eeg Review and Analysis Software, Persyst Development Corp. (2013) Summary page 4.

## Most influential descendants
- K190760: Cadwell Bolt Software (2019), 0 descendants of its own

## Indications for use
1) Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software. 2) The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information. 3) This device does not provide any diagnostic conclusion about the patient’s condition to the user. 4) Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Source page: https://510kreport.com/device/K161027
Methodology: https://510kreport.com/methodology