510(k) K251061 ยท JAK System, X-Ray, Tomography, Computed
NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jul 28, 2025 |
| Received | Apr 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | None listed |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha.Prime
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | None listed |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha.Pro
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.