# K210312: PlutoX Digital Intraoral X-Ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Apr 23, 2021 after 79 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: 4 generations back to K933455 (1994). 7 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 6.

## Most influential descendants
- K220422: Dental sensors NanoPix1, NanoPix2 (2022), 1 descendant of its own
- K230998: Digital Wireless Intraoral X-Ray Sensor (2023), 0 descendants of its own
- K232552: TuxDeluxe (Size 1 6100B, Size 2 6101B) (2023), 0 descendants of its own
- K230811: Digital Intraoral X-Ray Sensor (2023), 0 descendants of its own
- K212279: Digital Intraoral X-ray Imaging System (2021), 0 descendants of its own

## Indications for use
The Digital Intra-Oral X-Ray Imaging System (PlutoOOOX/PlutoOO02X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.

Source page: https://510kreport.com/device/K210312
Methodology: https://510kreport.com/methodology