SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO— 510(k) K192061
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K192061 for SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO, Substantially Equivalent on 2019-11-21. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code JAK
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192061
K-number listed on FDA's recall record- Z-0962-2022 — 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 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
- Z-1253-2021 — 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 (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192061.
Data sourced from openFDA. This site is unofficial and independent of the FDA.