ARTIS icono (Ceiling Configuration)— 510(k) K221516
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K221516 for ARTIS icono (Ceiling Configuration), Substantially Equivalent on 2022-07-19. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OWB
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K221516
K-number listed on FDA's recall record- Z-2648-2026 — ARTIS icono ceiling. Model Number: 11328100.
- Z-2241-2024 — ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Z-0523-2024 — ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221516.
Data sourced from openFDA. This site is unofficial and independent of the FDA.