510(k) K181550 ยท OWB Interventional Fluoroscopic X-Ray System
Cios Spin
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Jun 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181550
| 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 Spin, 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 clinical Terminated |
OWB | None listed |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures Terminated |
OWB | None listed |
| May 4, 2020 | Siemens Medical Solutions USA, Inc Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194 Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.