# K160788: RIOScan (RPS500)

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: Apr 15, 2016 after 24 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: 3 generations back to K934949 (1994). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133231: Digora Optime, Instrumentarium Dental, Palodex Group OY (2014) Summary page 5.
- K131442: Firecr Dentalimaging System, 3Disc Americas (2013) Summary page 5.

## Most influential descendants
- K170733: ScanX Intraoral View (2017), 5 descendants of its own
- K212080: Imaging Plate Scanner, i-Scan (2021), 1 descendant of its own
- K202633: ScanX Edge (2020), 1 descendant of its own
- K231660: Digital image scanner of dental (2023), 0 descendants of its own
- K230095: ScanX Swift 2.0, ScanX Swift View 2.0 (2023), 0 descendants of its own

## Indications for use
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental subspecialists. The system captures, digitizes, displays and sores diagnostic intraoral radiographic images.

Source page: https://510kreport.com/device/K160788
Methodology: https://510kreport.com/methodology