ARTIS pheno (VE2)— 510(k) K201156
Substantially EquivalentSiemens Medical Solution USA, Inc.
FDA 510(k) clearance K201156 for ARTIS pheno (VE2), Substantially Equivalent on 2020-06-29. Applicant: Siemens Medical Solution USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solution 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 Solution 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 K201156
K-number listed on FDA's recall record- Z-1294-2022 — Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
- Z-0987-2022 — Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
- 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-0515-2022 — Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
- Z-2029-2021 — ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201156.
Data sourced from openFDA. This site is unofficial and independent of the FDA.