# K192766: Digital Intraoral Imaging Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Fsusen Technology Co., Ltd.
- Decided: Dec 5, 2019 after 66 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K214091: Dental Image Plate Scanner, Model DFC-4T-SMART (2022), 0 descendants of its own

## Indications for use
Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media. And it is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.

Source page: https://510kreport.com/device/K192766
Methodology: https://510kreport.com/methodology