provoyance.comPreview Shoulder
Genesis Software Innovations
GENESIS SOFTWARE INNOVATIONS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019541896 | 3019541896 | GENESIS SOFTWARE INNOVATIONS | 1 | N | 2026-01-01 | 2851 Charlevoix Dr. SE Suite 327 Grand Rapids MI US 49546 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B973PREOPSHOULDER0 | ProVoyance PreOp Shoulder - The PreOp 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. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of thepatient'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.Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/ | 6162941026 | shoulder-support@provoyance.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 293771 | 1770120393 | K210556 | Preview Shoulder | QIH | 2021-04-21 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QIH | 1 | 2021-04-21 |
PMN#
Preview Shoulder
Genesis Software Innovations
GUDID#
ProVoyance PreOp Shoulder - The PreOp 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. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of thepatient'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.Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
2024-05-31
Preview - The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users. The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
2022-09-27