510(k) K132094 ยท OWB Interventional Fluoroscopic X-Ray System
CIOS ALPHA
| Applicant | Siemens Medi Cal Solutions, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Mar 11, 2014 |
| Received | Jul 8, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2020 | Siemens Medical Solutions USA, Inc Cios Alpha (VA20) - Model: 10308191
Cios Alpha (VA30) - Model: 11105200
Cios Spin (VA30) - Model: 10308194
Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the Terminated |
OWB | None listed |
| Jan 7, 2020 | Siemens Medical Solutions USA, Inc Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application Terminated |
OWB | None listed |
| Jun 20, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha VA20/ VA30 mobile X-Ray systems Terminated |
OWB | None listed |
| Mar 18, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica Terminated |
OWB | None listed |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc Cios Alpha, mobile X-ray system Terminated |
OWB | None listed |
| Feb 16, 2016 | Siemens Medical Solutions USA, Inc CIOS ALPHA (Image-intensified fluoroscope x-ray system)
Product Usage:
The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica Terminated |
OWB | None listed |
| Aug 17, 2015 | Siemens Medical Solutions USA, Inc CIOS ALPHA; image intensified fluoroscopic x-ray system Terminated |
OWB | None listed |
| Jul 2, 2015 | Siemens Medical Solutions USA, Inc Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are n Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.