13 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 19, 2025
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 28, 2024
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
FDA Enforcement
Class II
·Ongoing·First Source Inc·July 10, 2024
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
FDA Enforcement
Class II
·Ongoing·First Source Inc·July 10, 2024
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024
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
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 18, 2025
OEC 3D
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·June 18, 2025