Identity
- Trade Name
- Preview FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.29.1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- PREVIEWSHOULDER FDA UDI
- Primary DI / UDI-DI
- B973PREVIEWSHOULDER0 FDA UDI
- 510(k) Number
- K210556 FDA UDI
- FDA Product Code
- QIH FDA UDI
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Image segmentation application software
Preview by Genesis Software Innovations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Image segmentation application software.
- DYONICS — Smith & Nephew, Inc. · Class II
- DYONICS — Smith & Nephew, Inc. · Class II
- DYONICS — Smith & Nephew, Inc. · Class II
- BrainInsight — Hyperfine Operations, Inc. · Class II
- Neosoma Glioma — Neosoma, Inc. · Class II
- Iris — Intuitive Surgical, Inc. · Class II
- inHEART MODELS Shaper — INHEART · Class II
- Neosoma Dashboard — Neosoma, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genesis Software Innovations
Sources (1)
- FDA UDI a604759a-0685-495a-aa63-e4e8b36f2a6d 35 fields · synced Jun 6, 2026