AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM— 510(k) K052202
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K052202 for AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM, Substantially Equivalent on 2006-03-07. 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 K052202
K-number listed on FDA's recall record- Z-1496-2021 — Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.
- Z-2012-2019 — AXIOM Artis FC, Model Number 5904433
- Z-2013-2019 — AXIOM Artis FA, Model Number 5904441
- Z-2014-2019 — AXIOM Artis MP, Model Number 5904466
- Z-2015-2019 — AXIOM Artis BC, Model Number 5904649
- Z-2016-2019 — AXIOM Artis BA, Model Number 5904656
- Z-2017-2019 — AXIOM Artis dBC, Model Number 5917054
- Z-2018-2019 — AXIOM Artis TA, Model Number 7007755
- Z-2019-2019 — AXIOM Artis dTA, Model Number 7008605
- Z-2020-2019 — AXIOM Artis dFC, Model Number 7412807
- Z-2021-2019 — AXIOM Artis dTC, Model Number 7413078
- Z-2022-2019 — AXIOM Artis dBA, Model Number 7555357
- Z-2023-2019 — AXIOM Artis dMP, Model Number 7555365
- Z-2024-2019 — AXIOM Artis dFA, Model Number 7555373
- Z-2025-2019 — AXIOM Artis dFC, Model Number 7727717
- Z-2026-2019 — AXIOM Artis TC, Model Number 7728350
- Z-2027-2019 — AXIOM Artis dBC, Model Number 7728392
- Z-0711-2018 — Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Z-0708-2018 — Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
- Z-1468-2017 — Axiom Artis fluoroscopic x-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052202.
Data sourced from openFDA. This site is unofficial and independent of the FDA.