SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence— 510(k) K190578
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K190578 for SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence, Substantially Equivalent on 2019-06-27. 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
- Malvern, 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 K190578
K-number listed on FDA's recall record- Z-0472-2022 — SOMATOM Confidence -Computed tomography systems Model 10590100
- Z-0473-2022 — SOMATOM Definition AS-Computed tomography system Model 8098027
- Z-0474-2022 — SOMATOM Edge Plus-Computed tomography system Model 1026700
- Z-0475-2022 — SOMATOM Definition Edge -Computed tomography system Model 10590000
- Z-0283-2022 — SOMATOM Force with software syngo.CT VB20 Model #10742326
- Z-0284-2022 — SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
- Z-0285-2022 — SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
- Z-0286-2022 — SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
- Z-0287-2022 — SOMATOM Drive with software syngo.CT VB20 Model #10431700
- Z-0288-2022 — SOMATOM Confidence with software syngo.CT VB20 Model #10590100
- Z-0289-2022 — SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
- Z-2440-2019 — syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
- Z-2270-2019 — SOMATOM Definition Flash, Model Number 10430603 - 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).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190578.
Data sourced from openFDA. This site is unofficial and independent of the FDA.