ClearanceBrief
510(k) K173639 ยท OWB Interventional Fluoroscopic X-Ray System

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

ApplicantSiemens Medi Cal Solutions, Inc., Malvern PA, US
DecisionSubstantially Equivalent, Apr 2, 2018
ReceivedNov 24, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K173639

DateFirm and productCodeLinked 510(k)
Jan 8, 2026Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Open, Classified
OWBNone listed
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia. Model Number: 10094910
Open, Classified
JAANone listed
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473
Open, Classified
JAANone listed
Aug 7, 2024Siemens 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
OWBNone listed
Aug 7, 2024Siemens 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
OWBNone listed
Aug 7, 2024Siemens 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
OWBNone listed
May 23, 2023Siemens Medical Solutions USA, Inc
Luminos Agile Max (VE10, VF10, VF11)
Open, Classified
OWBNone listed
May 23, 2023Siemens Medical Solutions USA, Inc
Luminos dRF Max (VE10, VF10, VF11)
Open, Classified
OWBNone listed
May 23, 2023Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max (VF11)
Open, Classified
OWBNone listed
Feb 23, 2023Siemens 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
OWBNone listed
Feb 23, 2023Siemens 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
OWBNone listed
Feb 23, 2023Siemens 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
OWBNone listed
Jan 20, 2023Siemens Medical Solutions USA, Inc
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Open, Classified
OWBNone listed
Sep 9, 2020Siemens 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
JAANone listed
Jan 8, 2020Siemens 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
OWBNone listed
Jan 8, 2020Siemens 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
OWBNone listed
Jan 8, 2020Siemens 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
OWBNone listed
Jan 8, 2020Siemens 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
OWBNone listed
Jan 8, 2020Siemens 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
OWBNone listed
Jan 8, 2020Siemens 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
JAANone listed
Jan 8, 2020Siemens 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
JAANone listed
Jan 8, 2020Siemens 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
JAANone listed
Feb 8, 2019Siemens 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
OWBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.