Artis zee/zeego & Artis Q/Q.zen— 510(k) K181407
Substantially EquivalentSiemens Medical Solution USA, Inc.
FDA 510(k) clearance K181407 for Artis zee/zeego & Artis Q/Q.zen, Substantially Equivalent on 2018-08-15. 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 K181407
K-number listed on FDA's recall record- Z-1598-2024 — Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
- Z-1040-2023 — System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
- Z-1645-2022 — Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
- Z-1343-2022 — Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
- Z-0967-2022 — Artis zee floor, Model Number 10094135
- Z-0968-2022 — Artis zee ceiling, Model Number 10094137
- Z-0969-2022 — Artis zee multi-purpose, Model Number 10094139
- Z-0970-2022 — Artis zee biplane, Model Number 10094141
- Z-0971-2022 — Artis zee floor MN, Model Number 10094142
- Z-0972-2022 — Artis zee biplane MN, Model Number 10094143
- Z-0973-2022 — Artis zeego, Model Number 10280959
- Z-0974-2022 — Artis Q floor, Model Number 10848280
- Z-0975-2022 — Artis Q ceiling, Model Number 10848281
- Z-0976-2022 — Artis Q biplane, Model Number 10848282
- Z-0977-2022 — Artis Q zeego, Model Number 10848283
- Z-0978-2022 — Artis Q.zen floor, Model Number 10848353
- Z-0979-2022 — Artis Q.zen ceiling, Model Number 10848354
- Z-0980-2022 — Artis Q.zen biplane, Model Number 10848355
- Z-0296-2022 — Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
- Z-0297-2022 — Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181407.
Data sourced from openFDA. This site is unofficial and independent of the FDA.