510(k) K111292 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
LUMINOS AGILE
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jun 3, 2011 |
| Received | May 6, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc AXIOM Luminos Agile Open, Classified |
JAA | None listed |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications i Terminated |
JAA | 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 Luminos Agile Max system
The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.