# K211014: Portray

- Pathway: 510(k) (Traditional)
- Applicant: Surround Medical Systems
- Decided: Jul 28, 2021 after 114 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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: 6 generations back to K935046 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182206: RiX70 DC, Trident S.R.L (2018) Summary page 4.

## Most influential descendants
- K223780: Lumos 3DX (2023), 0 descendants of its own

## Indications for use
The Portray System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.

Source page: https://510kreport.com/device/K211014
Methodology: https://510kreport.com/methodology