# K231202: QuickRayPRO

- Pathway: 510(k) (Traditional)
- Applicant: Denterprise International, Inc.
- Decided: Jun 22, 2023 after 56 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO 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 a patient.

Source page: https://510kreport.com/device/K231202
Methodology: https://510kreport.com/methodology