# K241681: Overjet Image Enhancement Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Sep 9, 2024 after 90 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922470 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223623: SubtleMR (2.3.x), Subtle Medical, Inc. (2023) Summary page 5.

## Indications for use
Overjet Image Enhancement Assist is an image processing software that can be used for image enhancement in dental radiographs viewed in the Overjet device platform. It is an optional tool to be used for image quality enhancement. The software improves image quality by: - Reducing Noise: Utilizing a learning-based algorithm for noise reduction in bitewing and periapical images. - Enhancing Contrast and Sharpness: Applying standard, non-learning based techniques to enhance contrast and sharpness for bitewing, periapical, and panoramic images. Raw images will be acquired and reviewed using the dental clinics standard imaging acquisition and viewing software. This device is part of the Overjet platform alone, it is not intended to replace their own diagnostic imaging system.

Source page: https://510kreport.com/device/K241681
Methodology: https://510kreport.com/methodology