ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)— 510(k) K241572
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K241572 for ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A), Substantially Equivalent on 2024-10-22. 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 K241572
K-number listed on FDA's recall record- Z-2641-2026 — ARTIS icono biplane. Model Number: 11327600.
- Z-2642-2026 — ARTIS icono ceiling. Model Number: 11328100.
- Z-2643-2026 — ARTIS icono floor. Model Number: 11327700.
- Z-1814-2026 — ARTIS Pheno VE30A and VE40A, Model 10849000
- Z-1653-2026 — ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Z-2529-2025 — Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
- Z-2020-2025 — interventional fluoroscopic x-ray system
- Z-2021-2025 — interventional fluoroscopic x-ray system
- Z-2022-2025 — interventional fluoroscopic x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.