Medical diagnostic company Shimadzu Medical Systems USA reported on Monday the receipt of the US FDA 510(k) clearance for the patient side conventional radiographic/fluoroscopic (RF) table system, FLUOROspeed X1.
With immediate market launch, the company's new radiographic/fluoroscopic (RF) FLUOROspeed X1 table system offers a high image quality and a multitude of features that improve work flow and operator efficiencies which contributes to lower cost of care.
A part of the FLUOROspeed series, the company's new FLUOROspeed X1 with its 665lb static patient weight and 500lb all motion weight, easily performs both bariatric and routine daily fluoroscopic and radiographic exams. It is practically priced and comes equipped with a 17"x17" dynamic digital X-ray detector (FPD) in the table bucky allowing be used for both fluoroscopy as well as radiographic exams.
The 31.5-inch aperture opening between table top and deck also provides access for imaging patients in wheelchairs as well as fits in smaller rooms. Adding the second X-ray tube on an overhead rail, the FLUOROspeed X1's functionality and versatility increases exponentially, concluded the company.
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
MaaT Pharma outlines potential Phase 3 development plan for MaaT013 after CHMP negative opinion
Bayer's Kerendia wins FDA approval for chronic kidney disease associated with type 1 diabetes
Myosin Therapeutics chosen for 2026-2027 NCI Investor Initiatives Showcase
Medtronic receives FDA clearance for LigaSure RAS Maryland instrument on Hugo system
VaxThera partners with Codagenix for next generation yellow fever vaccine advancement
MaaT Pharma receives negative CHMP trend vote for MaaT013
FDA approves Scholar Rock's ISEMBYLD to treat spinal muscular atrophy
FDA grants priority review to Takeda's zasocitinib application for plaque psoriasis
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Eloxx Pharmaceuticals commences Phase 2b study of exaluren
Meant Health announces expansion of telehealth access for FDA-approved GLP-1 prescriptions
US FDA grants orphan drug designation for Lundbeck's asedebart