# K240172: Preview Shoulder

- Pathway: 510(k) (Special)
- Applicant: Genesis Software Innovations
- Decided: Apr 4, 2024 after 73 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: 10 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210556: Preview Shoulder, Genesis Software Innovations (2021) Summary page 4.

## Indications for use
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Source page: https://510kreport.com/device/K240172
Methodology: https://510kreport.com/methodology