3D-Side SA radiology AI products

Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

Prepare with a buyer guide:

Radiology AI pricing and total cost of ownership

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K221432

Customize

3D-Side SA

Customize supports adult total ankle arthroplasty planning with CT segmentation, 3D models, implant positioning and sizing, plan review, and X-ray-informed planning.

Modality: CT/CTA
Anatomy: Foot/Ankle
Decision: 2022-08-03

MSK and bone Quantification and segmentation

FDA-cleared K213779

Authorized purpose: Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it is not for diagnosis, spine surgery, or implant and instrument design.

Modality: CT/CTA
Anatomy: Shoulder
Decision: 2022-03-16

MSK and bone Quantification and segmentation