ARTIS ZEE / ZEEGOS WITH SW VC14— 510(k) K090745
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K090745 for ARTIS ZEE / ZEEGOS WITH SW VC14, Substantially Equivalent on 2009-06-18. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code IZI
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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 K090745
K-number listed on FDA's recall record- Z-0710-2018 — Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Z-1782-2013 — ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
- Z-1945-2013 — Siemens AXIOM Artis zeego x-ray, angiographic system
- Z-0997-2013 — Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
- Z-1750-2013 — Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
- Z-0172-2014 — Artis zee systems x-ray, angiographic system
- Z-0992-2013 — Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090745.
Data sourced from openFDA. This site is unofficial and independent of the FDA.