# K241649: DUO1 and DUO2

- Pathway: 510(k) (Traditional)
- Applicant: Zinnovi, Inc.
- Decided: Jul 5, 2024 after 28 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)
- K221955: Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20, Realcloud Imaging Inc. Dba Realcloud Imaging (2022) Summary page 4.

## Indications for use
The DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs. The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient.

Source page: https://510kreport.com/device/K241649
Methodology: https://510kreport.com/methodology