# K212080: Imaging Plate Scanner, i-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Sep 27, 2021 after 87 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: 5 generations back to K934949 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170733: ScanX Intraoral View, Duerr Dental AG (2017) Summary page 4.

## Most influential descendants
- K231660: Digital image scanner of dental (2023), 0 descendants of its own

## Indications for use
i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

Source page: https://510kreport.com/device/K212080
Methodology: https://510kreport.com/methodology