# K220422: Dental sensors NanoPix1, NanoPix2

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Mar 11, 2022 after 25 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 K933455 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210312: PlutoX Digital Intraoral X-Ray Imaging System, Iray Technology Taicang, Ltd. (2021) Summary page 6.

## Most influential descendants
- K232552: TuxDeluxe (Size 1 6100B, Size 2 6101B) (2023), 0 descendants of its own

## Indications for use
Dental Sensors, models NanoPix1 and NanoPix2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygenrich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric.

Source page: https://510kreport.com/device/K220422
Methodology: https://510kreport.com/methodology