Radiaction Medical Gains Additional 510(k) Clearance for Radiation Shielding System
Radiaction Medical has gained an additional 510(k) clearance from the FDA for its Radiaction Shield System for use with Siemens’ Artis fluoroscopy C-arm machines.
The Shield System will work as an accessory to new and legacy Artis C-arm models, the company said.
Medical teams working with X-ray fluoroscopy in catheterization laboratories are exposed to high levels of scattered radiation in their heads, arms and legs because they are not protected by the lead aprons they wear.
Clinical studies demonstrated that Radiaction’s shield system reduces radiation in a laboratory by over 90 percent, with higher reduction rates to the head and upper bodies of medical team members, the Tel Aviv, Israel-based company said.