510(k) K200524 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Apr 1, 2020 |
| Received | Mar 2, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200524
| 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 |
| 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 7, 2022 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr Terminated |
JAK | None listed |
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A afte Terminated |
JAK | None listed |
| Sep 10, 2021 | Siemens Medical Solutions USA, Inc syngo.CT VA20A, VA30A and VA40A in:
syngo.via RT Image Suite / Sim&Go
SOMATOM go.Now
SOMATOM go.Up
SOMATOM go.All
SOMATOM go.Top
SOMATOM go.Sim
SOMATOM go.Open Pro and
SOMATOM X.cite
Material Open, Classified |
JAK | None listed |
| Aug 18, 2021 | Siemens Medical Solutions USA, Inc Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems:
SOMATOM go.Up - Model 11061620
SOMATOM go.Up - Model 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.