Fujifilm awarded FDA 510(k) for dry laser imagers with FFDM

TriMed Staff | | Health Imaging | Diagnostic Imaging
The FDA has given 510(k) clearance to Fujifilm Medical Systems USA Inc.'s DryPix dry laser imagers for use with full-field digital mammography (FFDM).

The clearance covers the company's DryPix 7000, DryPix 5000 and DryPix FM-DP L models. The centralized dry laser imagers have both regulatory clearance and inherent features necessary for printing FFDM, as well as computed radiography, MRI, CT and ultrasound.

All three imagers have been tested and validated by FFDM pre-market application (PMA) holders GE Medical Systems, Fischer Imaging Corp. and Hologic Inc.

TriMed Staff

Related Content

AI rules out abnormal findings on chest X-rays, significantly reducing workloads
Older adults among the walking wounded with incident TBI
Philips moves digital pathology to the cloud with AWS
PHOTO GALLERY: What does fetal medical imaging look like?
Speaker laments radiology’s major contribution to climate change
Radiologist accuracy takes a hit overnight, especially with advanced imaging exams

Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

Design by Adaptive Theme
Trimed Popup
Trimed Popup