ARTIS ZEE/ZEEGO SW VC21— 510(k) K141574
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K141574 for ARTIS ZEE/ZEEGO SW VC21, Substantially Equivalent on 2014-09-05. 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
- Special
- Location
- Mavern, 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 K141574
K-number listed on FDA's recall record- Z-2526-2018 — Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
- Z-2308-2018 — Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2309-2018 — Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2310-2018 — Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2311-2018 — Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2312-2018 — Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2313-2018 — Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
- Z-2314-2018 — Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
- Z-0710-2018 — Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Z-0971-2017 — Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are 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 zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
- Z-0602-2017 — Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are 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 zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
- Z-1846-2015 — Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141574.
Data sourced from openFDA. This site is unofficial and independent of the FDA.