510(k) K220814 ยท JAK System, X-Ray, Tomography, Computed
NAEOTOM Alpha, Scan&GO Software
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jul 12, 2022 |
| Received | Mar 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc Software :
myNeedle Guide 2D license,
myNeedle Guide 2D AWP only Workflow license, or
myNeedle Guide 3D license.
Used on the following CT (Computed tomography systems):
SOMATOM go.Now Model 11061610 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.