# K052338: Solar GI

- Pathway: 510(k) (Special)
- Applicant: Medical Measurement Systems B.V.
- Decided: Dec 15, 2005 after 111 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091070: Manoscan Motility with Impedance Visualization System (2009), 1 descendant of its own
- K240007: Solar Compact (G4-1) (2024), 0 descendants of its own
- K151086: ManoScan System (2016), 0 descendants of its own

## Indications for use
The Solar GI system is intended to record, store, view and analyse pressure, EMG, input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

Source page: https://510kreport.com/device/K052338
Methodology: https://510kreport.com/methodology