# K182198: Panoura X-ERA PF/NF/MF

- Pathway: 510(k) (Traditional)
- Applicant: The Yoshida Dental Mfg. Co., Ltd.
- Decided: Jan 31, 2019 after 170 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: 8 generations back to K973598 (1997). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122806: Image Works Panoura, Mic International (2013) Summary page 6.

## Most influential descendants
- K222666: X-View 3D Pan/X-View 2D Pan (2023), 0 descendants of its own

## Indications for use
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K182198
Methodology: https://510kreport.com/methodology