# K230916: WeSensor

- Pathway: 510(k) (Traditional)
- Applicant: Picopack, Inc.
- Decided: Oct 10, 2023 after 190 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151926: QuickRay HD Intraoral Sensor, Denterprise International, Inc. (2015) Summary page 5.
- K220277: Digital Intraoral X-ray Sensor, Shenzhen Xpectvision Technology Co., Ltd. (2022) Summary page 5.
- K153060: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S, Rayence Co., Ltd. (2015) Summary page 6.

## Indications for use
The WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

Source page: https://510kreport.com/device/K230916
Methodology: https://510kreport.com/methodology