# K090458: Dexis Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Dexis, LLC
- Decided: May 28, 2009 after 94 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: 3 generations back to K933455 (1994). 6 ancestors in all.
18 later devices descend from it; 7 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072134: Schick Computed Oral Radiology System, Schick Technologies, Inc. (2007) Summary page 2.
- K070219: Suniray II Digital Radiography System, Suni Medical Imaging, Inc. (2007)

## Most influential descendants
- K210312: PlutoX Digital Intraoral X-Ray Imaging System (2021), 5 descendants of its own
- K202664: Clio Prime and Clio Pedo (2020), 2 descendants of its own
- K172918: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) (2017), 2 descendants of its own
- K221955: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (2022), 1 descendant of its own
- K220422: Dental sensors NanoPix1, NanoPix2 (2022), 1 descendant of its own

## Indications for use
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Source page: https://510kreport.com/device/K090458
Methodology: https://510kreport.com/methodology