ARTIS pheno— 510(k) K163286
Substantially EquivalentSiemens Medical Solution USA, Inc.
FDA 510(k) clearance K163286 for ARTIS pheno, Substantially Equivalent on 2017-03-09. 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 K163286
K-number listed on FDA's recall record- Z-1311-2023 — ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
- Z-1498-2023 — ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
- Z-0956-2023 — ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
- Z-0119-2023 — ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 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-2029-2021 — ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
- Z-2108-2020 — ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: 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-1340-2020 — ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
- Z-0807-2020 — Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Z-1905-2019 — Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
- Z-3190-2018 — ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Z-2748-2018 — ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
- Z-2524-2018 — ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
- Z-2283-2018 — ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163286.
Data sourced from openFDA. This site is unofficial and independent of the FDA.