SOMATOM FORCE— 510(k) K133589
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K133589 for SOMATOM FORCE, Substantially Equivalent on 2014-04-17. 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
- Mavern, PA, 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 K133589
K-number listed on FDA's recall record- Z-0771-2021 — SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
- Z-3025-2020 — Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
- Z-0406-2020 — Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
- Z-2274-2019 — SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
- Z-0692-2017 — SOMATOM Force, System x-ray, tomography, computed
- Z-1558-2016 — SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
- Z-0107-2016 — SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
- Z-1267-2015 — SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Z-0971-2015 — SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133589.
Data sourced from openFDA. This site is unofficial and independent of the FDA.