510(k) K062623 ยท OWB Interventional Fluoroscopic X-Ray System
AXIOM LUMINOS DRF
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Aug 22, 2007 |
| Received | Sep 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile with software VC10 - A diagnostic imaging system for
radiographic and fluoroscopic studies.
Model Number: 10502200 Open, Classified |
OWB | None listed |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF with software VD10- A diagnostic imaging system for
radiographic and fluoroscopic studies
Model Number: 10094200 Open, Classified |
OWB | None listed |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general Terminated |
OWB | 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 AXIOM Luminos dRF Max systems
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, Terminated |
KPR | None listed |
| Sep 16, 2014 | Siemens Medical Solutions USA, Inc AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a d Terminated |
OWB | 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 AXIOM Luminos dRFsystem
The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform Terminated |
OWB | None listed |
| Nov 27, 2013 | Siemens Medical Solutions USA, Inc Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G
Image intensified Fluoroscopic X-ray system Terminated |
JAA | 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 |
| Aug 1, 2013 | Siemens Medical Solutions USA, Inc Siemens Luminos dRF Fluoroscopic X-Ray system
Fluoroscopic X-Ray system Terminated |
OWB | None listed |
| Apr 9, 2012 | Siemens Medical Solutions USA, Inc Siemens Axiom Luminos dRF solid state x-ray imager
Solid state x-ray imager (flat panel/dig. imager) Terminated |
MQB | 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 |
| Feb 23, 2011 | Siemens Medical Solutions USA, Inc AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS
System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager) Terminated |
MQB | None listed |
| Dec 17, 2010 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF
Intended use: solid state x-ray imager (flat panel/digital imager) Terminated |
MQB | None listed |
| Aug 13, 2010 | Siemens Medical Solutions USA, Inc SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system. Terminated |
MQB | None listed |
| Nov 28, 2008 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047.
Universal fluoroscopic x-ray diagnostic system. Terminated |
MQB | None listed |
| Nov 28, 2008 | Siemens Medical Solutions USA, Inc Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048.
Universal fluoroscopic x-ray diagnostic system. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.