Regulatory: Page 244

AMS gets Catella 510(k)
By AuntMinnie.com staff writers
American Medical Sales has received Food and Drug Administration 510(k) marketing clearance for its new PACS workstation software, Catella Version 4.0.
November 22, 2005
CardiArc seeks clearance for SPECT
By AuntMinnie.com staff writers
Cardiac imaging device developer CardiArc reported that it submitted a premarket notification 510(k) application with the Food and Drug Administration for a SPECT imaging device last month.
November 22, 2005
Toshiba notches 510(k) for Infinix VC-i
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received Food and Drug Administration 510(k) marketing clearance for its Infinix VC-i system with a large field-of-view 12 x 16-inch flat-panel detector.
November 21, 2005
Draxis iodine kit gets FDA approval
By AuntMinnie.com staff writers
Draxis Health reported that the FDA has approved its DraxImage division's new, larger format of its HiCon kit for the preparation of sodium iodide I-131 capsules and oral solution.
November 21, 2005
Radlink gets FDA approval for CR Pro
By AuntMinnie.com staff writers
Radiography equipment manufacturer Radlink of Torrance, CA, has received FDA clearance for the marketing and sale of its CR Pro computed radiography device.
November 17, 2005
Kodak starts FDA process for CR mammo
By AuntMinnie.com staff writers
Eastman Kodak Health Group has begun the submission process to the Food and Drug Administration for approval to apply its computed radiography (CR) technology to mammography applications.
November 16, 2005
CE Mark for MR Instruments
By AuntMinnie.com staff writers
MRI device developer MR Instruments of Minneapolis reported it has received European CE Mark approval for its transverse electromagnetic (TEM) single-channel, transmit/receive, 15-element tuned-array head and extremity coils for 3-tesla MRI.
November 16, 2005
Neoprobe, UCSD granted European patent for Lymphoseek
By AuntMinnie.com staff writers
Dublin, OH-based Neoprobe announced that the University of California, San Diego (UCSD), recently received a European patent covering Lymphoseek.
November 15, 2005
ICAMRL resurrects MR lab accreditation program
By AuntMinnie.com staff writers
The Intersocietal Commission for the Accreditation of Magnetic Resonance Laboratories (ICAMRL) has revived its accreditation program for MR labs.
November 8, 2005
CMS sets 2007 deadline for nuclear medicine self-referral
By AuntMinnie.com staff writers
In a nod to marketplace realities, the U.S. Centers for Medicare and Medicaid Services (CMS) has set an effective date of 2007 for a regulatory change prohibiting the self-referral of patients in diagnostic nuclear medicine and therapeutic nuclear medicine.
November 6, 2005
Planmed
By Kate Madden Yee
At the RSNA show, Planmed of Roselle, IL, will highlight two mammography systems: Planmed Nuance Classic and the work-in-progress Nuance, a full-field digital mammography unit.
November 6, 2005
2005 11 04 16 50 09 706
Fujifilm Medical Systems USA
By Kate Madden Yee
Stamford, CT-based Fujifilm Medical Systems USA will highlight multiple versions of its Fuji CR for Mammography (FCRm) technology, as well as its Multi-Modality Breast Imaging Workstation.
November 6, 2005
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