je.st
news
Tag: 510k
Elekta receives US 510(k) clearance for its latest generation...
2015-08-05 17:53:14| Appliances - Topix.net
Elekta's Leksell Gamma Knife Icona radiosurgery system has received 510 clearance from the US Food and Drug Administration, enabling US health care providers to offer this advanced technology to their patients. With stereotactic imaging, online Adaptive DoseControla , ultra-precise dose delivery and the availability of frameless treatments, Icon is capable of treating virtually any target in the brain, regardless of type, location or volume.
Tags: latest
generation
clearance
receives
PCI Medical Announces 510(k) Submission to FDA for Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Probes
2015-04-02 12:31:11| Industrial Newsroom - All News for Today
PCI Medical announces that it has submitted the GUS ASTRA VR and GUS ASTRA TEE to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, and that the submission is now in substantive review. The GUS ASTRA VR is an automated reprocessor for the high-level disinfection of endovaginal/endorectal...
Tags: medical
submission
tee
automated
Covidien's Fortrex PTA Balloon Receives FDA 510(k) Clearance
2014-11-25 00:06:10| Industrial Machines - Topix.net
Covidien plc today announced U.S. Food and Drug Administration 510 clearance for its Fortrexa over-the-wire percutaneous transluminal angioplasty balloon catheter. The Fortrexa 0.035" OTW PTA balloon catheter -the next-generation high pressure solution to maintain arteriovenous access-is also intended for use in the peripheral vascular system.
Tags: clearance
receives
balloon
fda
Covidien Announces U.S. Food and Drug Administration 510(k) Clearance ...
2014-10-10 04:51:58| Industrial Machines - Topix.net
Covidien plc today announced U.S. Food and Drug Administration 510 clearance for the Nellcor Portable SpO2 Patient Monitoring System . The system is the only commercially available portable oximeter that is equipped with home care and sleep study modes and complies with Part of a comprehensive Covidien respiratory function monitoring portfolio, this convenient, handheld patient monitor is simple to use and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation .
Tags: food
administration
drug
clearance
Blockade Medical Announces 510(k) Clearance And CE Mark Of Two New Additions To The Barricade Coil System
2014-03-05 04:48:51| drugdiscoveryonline Home Page
Blockade Medical L.L.C., a privately held company focused on the development of catheter based therapeutic devices for the treatment of cerebral aneurysms, recently announced two additions to the Barricade Coil System including an Enhanced Framing Coil and a new Complex Finishing Coil