# K232552: TuxDeluxe (Size 1 6100B, Size 2 6101B)

- Pathway: 510(k) (Abbreviated)
- Applicant: Tuxedo Imaging, LLC
- Decided: Oct 20, 2023 after 58 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: 6 generations back to K933455 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220422: Dental sensors NanoPix1, NanoPix2, Iray Technology Taicang, Ltd. (2022) Summary page 4.

## Indications for use
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 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 oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.

Source page: https://510kreport.com/device/K232552
Methodology: https://510kreport.com/methodology