510(k) K133259 ยท KPR System, X-Ray, Stationary
YSIO MAX
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Oct 23, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the who Terminated |
KPR | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into Terminated |
KPR | None listed |
| Aug 6, 2018 | Siemens Medical Solutions USA, Inc Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body. Terminated |
KPR | None listed |
| Aug 1, 2016 | Siemens Medical Solutions USA, Inc YSIO Max
Product Usage:
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: Terminated |
KPR | None listed |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, Terminated |
KPR | None listed |
| Jan 16, 2015 | Siemens Medical Solutions USA, Inc Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license.
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max en Terminated |
KPR | None listed |
| Oct 2, 2014 | Siemens Medical Solutions USA, Inc Siemens Ysio Max system
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: sk Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.