510(k) K211373 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Aug 27, 2021 |
| Received | May 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211373
| 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.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgr Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.