SOMATOM Definition Edge— 510(k) K143401
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K143401 for SOMATOM Definition Edge, Substantially Equivalent on 2015-04-06. 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 K143401
K-number listed on FDA's recall record- 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-2626-2016 — SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
- Z-0019-2016 — SOMATOM Definition Edge; intended 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 angles 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 K143401.
Data sourced from openFDA. This site is unofficial and independent of the FDA.