# K151086: ManoScan System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Apr 28, 2016 after 372 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K821588 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091070: Manoscan Motility with Impedance Visualization System, Sierra Scientific Instruments, Inc. (2009) Summary page 5.
- K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID, Medtronic Functional Diagnostics A/S (2001) Summary page 5.

## Indications for use
The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by medically trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.

Source page: https://510kreport.com/device/K151086
Methodology: https://510kreport.com/methodology