# K173646: FS Ergo

- Pathway: 510(k) (Traditional)
- Applicant: Palodex Group OY
- Decided: Dec 19, 2017 after 22 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933455 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081925: Snapshot, Instrumentarium Dental, Palodex Group OY (2008) Summary page 4.
- K151707: EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i, Rayence Co., Ltd. (2015) Summary page 4.

## Indications for use
The FS Ergo sensor is a digital sensor which is indicated for acquiring dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.

Source page: https://510kreport.com/device/K173646
Methodology: https://510kreport.com/methodology