# K160386: ReadeR, VieweR, QuickScan PSP

- Pathway: 510(k) (Traditional)
- Applicant: Trident S.R.L
- Decided: Mar 10, 2016 after 28 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: 4 generations back to K934949 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143703: NICAL SMART MICRO CR system for intraoral dental images, Nical Spa (2015) Summary page 5.

## Indications for use
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Source page: https://510kreport.com/device/K160386
Methodology: https://510kreport.com/methodology