510(k) K192061 · JAK System, X-Ray, Tomography, Computed
SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Aug 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc SIEMENS SOMATOM with software syngo CT VA30A_SP4
Models:
SOMATOM go.Now 11061610 & 11061618
SOMATOM go.Up 11061620 & 11061628
SOMATOM go.All 11061630 & 11061638
SOMATOM go.Top 11061640 & 1106 Open, Classified |
JAK | None listed |
| Mar 3, 2021 | Siemens Medical Solutions USA, Inc Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows:
SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628)
SOMATOM go.All (Mo Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.