ARTIS Icono— 510(k) K193326
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K193326 for ARTIS Icono, Substantially Equivalent on 2020-04-16. 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 K193326
K-number listed on FDA's recall record- Z-1342-2022 — Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
- Z-1245-2022 — Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
- Z-1246-2022 — Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
- Z-0985-2022 — Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
- Z-0986-2022 — Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
- Z-1339-2022 — syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
- Z-0516-2022 — Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
- Z-0517-2022 — Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
- Z-1497-2021 — Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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-1288-2021 — Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Z-1144-2021 — ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
- Z-0400-2021 — ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: 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-2257-2020 — ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193326.
Data sourced from openFDA. This site is unofficial and independent of the FDA.