510(k) K181560 ยท OWB Interventional Fluoroscopic X-Ray System
Cios Alpha
| Applicant | Siemens Medical Systems USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Jun 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181560
| 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 |
| Jul 30, 2020 | Siemens Medical Solutions USA, Inc Cios Alpha, Image-Intensified Fluoroscopic X-Ray System
The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinica Terminated |
OWB | None listed |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Siemens Cios Alpha VA20-mobile X-Ray system
Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during Terminated |
OWB | None listed |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Siemens Cios Alpha VA30-mobile X-Ray system,
Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient durin Terminated |
OWB | None listed |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194
The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the a 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 22, 2019 | Siemens Medical Solutions USA, Inc Cios Alpha with software version VA30-mobile C-arm x-ray
Material # 11105200
Product Usage:
The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of p Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.