# K031801: Pantos, Models: Pantos 16, and Pantos DG

- Pathway: 510(k) (Traditional)
- Applicant: Blue X Imaging Srl
- Decided: Sep 11, 2003 after 92 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: 2 generations back to K961826 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972968: Rotograph Plus, Chicago X-Ray Systems, Inc. (1997) Summary page 2.
- K983283: Signet Dxis Direct X-Ray Imaging System, Signet Radiology, Inc. (1998) Summary page 2.
- K982661: CDR - Pan  Model 4700, Schick Technologies, Inc. (1998) Summary page 2.

## Most influential descendants
- K161131: FONA Pan/Ceph (2016), 0 descendants of its own

## Indications for use
The PantOs equipment, model PantOs 16, and PantOs DG are indicated for individuals requiring extra-oral dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures. It exposes and acquires radiographic images at the dentomaxiliofacial region. Depending on the model, the anatomical structures are visualized either on a radiographic film or on a computer display, through a dedicated image-intensified fluoroscopic x-ray system.

Source page: https://510kreport.com/device/K031801
Methodology: https://510kreport.com/methodology