510(k) K101491 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
UROSKOP OMNIA
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jun 30, 2010 |
| Received | Jun 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2025 | Siemens Medical Solutions USA, Inc UROSKOP Omnia. Model Number: 10094910 Open, Classified |
JAA | None listed |
| Jun 17, 2025 | Siemens Medical Solutions USA, Inc UROSKOP Omnia Max. Model Number: 10762473 Open, Classified |
JAA | None listed |
| Sep 9, 2020 | Siemens Medical Solutions USA, Inc Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive Terminated |
JAA | None listed |
| Feb 8, 2019 | Siemens Medical Solutions USA, Inc Uroskop Omnia -fluoroscopic X-ray system
Model # 10094910
The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, end Terminated |
JAA | None listed |
| May 23, 2015 | Siemens Medical Solutions USA, Inc SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The Terminated |
JAA | None listed |
| Oct 2, 2014 | Siemens Medical Solutions USA, Inc Siemens Uroskop Omnia Max system
The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal inv 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 |
| 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 |
| 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.