SOMATOM Definition AS Open (VA48)— 510(k) K143409
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K143409 for SOMATOM Definition AS Open (VA48), Substantially Equivalent on 2015-03-26. 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 K143409
K-number listed on FDA's recall record- Z-0373-2017 — SOMATOM Definition AS system, x-ray, tomography, computed
- Z-2624-2016 — SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143409.
Data sourced from openFDA. This site is unofficial and independent of the FDA.