MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS— 510(k) K021021
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K021021 for MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS, Substantially Equivalent on 2002-06-06. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iselin, NJ, US
Recent devices under product code JAA
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view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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 K021021
K-number listed on FDA's recall record- Z-2525-2018 — AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
- Z-1150-2018 — AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 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.
- Z-0711-2018 — Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Z-1310-2016 — AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
- Z-2108-2013 — Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021021.
Data sourced from openFDA. This site is unofficial and independent of the FDA.