510(k) K173632 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 13, 2018 |
| Received | Nov 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173632
| 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 |
| Sep 24, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top, Models 11061640 & 11061648-
a Computer tomography x-ray system Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Now;
Models #11061610 & 11061618
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up;
Models #11061620
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up;
Models ##11061628
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All;
Models #11061630
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All;
Models #11061638
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top;
Models #11061640
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Jul 31, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top;
Models #11061648
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi Terminated |
JAK | None listed |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up, Model No. 11061628
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images Terminated |
JAK | None listed |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Now, Model No. 11061618
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image Terminated |
JAK | None listed |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All, Model No. 11061638
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image Terminated |
JAK | None listed |
| Jun 4, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top, Model No. 11061648
with syngo.CT software versions VA20A,
VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image Terminated |
JAK | None listed |
| May 28, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of Terminated |
JAK | None listed |
| May 28, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images Terminated |
JAK | None listed |
| May 28, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images Terminated |
JAK | None listed |
| May 28, 2019 | Siemens Medical Solutions USA, Inc SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.