510(k) K081722 ยท KPR System, X-Ray, Stationary
YSIO
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Aug 22, 2008 |
| Received | Jun 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2022 | Siemens Medical Solutions USA, Inc Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system Open, Classified |
KPR | None listed |
| Mar 3, 2020 | Siemens Medical Solutions USA, Inc Ysio, model no. 10281013
Product Usage: The product is a stationary X-Ray system. Terminated |
KPR | None listed |
| Aug 6, 2018 | Siemens Medical Solutions USA, Inc Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body. Terminated |
KPR | None listed |
| Sep 23, 2014 | Siemens Medical Solutions USA, Inc The Ysio Systems with software version VC10
The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, a Terminated |
KPR | None listed |
| Sep 10, 2014 | Siemens Medical Solutions USA, Inc Siemens Luminos dRF, Ysio or Uroskop Omnia systems.
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Terminated |
JAA | None listed |
| Jun 21, 2014 | Siemens Medical Solutions USA, Inc Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G.
Product Usage: Image Intensified Fluoroscopic X-ray system Terminated |
KPR | None listed |
| Jun 4, 2014 | Siemens Medical Solutions USA, Inc Siemens Ysio Systems
Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures Terminated |
KPR | None listed |
| Nov 26, 2013 | Siemens Medical Solutions USA, Inc (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10
Image intensified fluoroscopic x-ray system Terminated |
KPR | None listed |
| Nov 1, 2013 | Siemens Medical Solutions USA, Inc Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E.
Fluroscopic X-Ray Systems Terminated |
OWB | None listed |
| Mar 5, 2012 | Siemens Medical Solutions USA, Inc Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia
Solid state x-ray imager (flat panel/digital imager) Terminated |
MQB | None listed |
| Jul 11, 2011 | Siemens Medical Solutions USA, Inc Siemens YSIO - solid state x-ray imager
Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.