Momentum Spine is an AI-enabled medical device from Momentum Health Inc., listed by FDA (510(k), K232023) with a decision date of 2023-10-04. Review panel: Radiology.
| FDA submission number | K232023 |
|---|---|
| Pathway | 510(k) |
| Company | Momentum Health Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-10-04 |
| Decision | Substantially Equivalent |
| Product code | LDK |
| Classification | Device, Sensing, Optical Contour |
| Device class | U |
| Review time (calendar days) | 89 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.