63 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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 digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 24, 2014
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, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 8, 2014
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.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 17, 2014
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.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2020
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 14, 2026
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 6, 2013
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 4, 2013
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 7, 2013
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 applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
FDA Enforcement
Class II
·Ongoing·Villa Sistemi Medicali S.P.A.·January 8, 2020
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 R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2015
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 applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023
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 a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 11, 2014
Luminos dRF Max (VE10, VF10, VF11)
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·May 31, 2023
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·February 13, 2013
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Enforcement
Class II
·Terminated·Villa Sistemi Medicali S.P.A.·March 15, 2017