510(k) K173639 ยท OWB Interventional Fluoroscopic X-Ray System
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
| Applicant | Siemens Medi Cal Solutions, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 2, 2018 |
| Received | Nov 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Siemens Medical Solutions USA, Inc LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Open, Classified |
OWB | None listed |
| 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 |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.
Model Number: 10762472 Open, Classified |
OWB | None listed |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.
Model Number: 10762471 Open, Classified |
OWB | None listed |
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
Model Number: 11574100 Open, Classified |
OWB | None listed |
| May 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max (VE10, VF10, VF11) Open, Classified |
OWB | None listed |
| May 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF Max (VE10, VF10, VF11) Open, Classified |
OWB | None listed |
| May 23, 2023 | Siemens Medical Solutions USA, Inc LUMINOS Lotus Max (VF11) Open, Classified |
OWB | None listed |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studies
Model Number: 10762472 Open, Classified |
OWB | None listed |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for
radiographic and fluoroscopic studie
Model Number:10762471 Open, Classified |
OWB | None listed |
| Feb 23, 2023 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for
radiographic and fluoroscopic studie
Model Number:10762473 Open, Classified |
OWB | None listed |
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max Open, Classified |
OWB | None listed |
| Sep 9, 2020 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal inva Terminated |
JAA | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical Terminated |
OWB | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has med Terminated |
OWB | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is desig Terminated |
OWB | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical Terminated |
OWB | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has med Terminated |
OWB | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Luminos dRF Max
Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Luminos Agile Max
Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | None listed |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Uroskop Omnia max
Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | None listed |
| Feb 8, 2019 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max -fluoroscopic X-ray system
Model # 10762473
Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.