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NEC RECEIVES FDA 510(K)
CLEARANCE ON MD215MG MEDICAL DIAGNOSTIC MONITOR
August 26, 2011
The
Food & Drug Administration has completed 510(k) market clearance of the
NEC 21.3-inch MultiSync MD215MG medical diagnostic display for the
displaying and viewing of digital mammography images for diagnosis by
trained physicians.
This 5-megapixel medical diagnostic display was created for medical
imaging and Picture Archiving and Communication System (PACS) in
hospitals, doctor offices, urgent care centers and other healthcare
facilities. The MD215MG is factory calibrated to the DICOM grayscale
function for luminance and includes a front sensor to maintain a
calibrated brightness and an ambient light sensor that automatically
adjusts the display's brightness based on existing lighting conditions.
"The clearance of the MD215MG marks the second FDA certification for the
MultiSync MD Series this year, which is a testament to NEC's commitment
to continually advancing the medical display market," said Art Marshall,
Product Manager for Professional Desktop and Medical Displays at NEC
Display Solutions. "The MD215MG is designed specifically with healthcare
professionals in mind and offers reliable screen performance with
functional technologies that are required to be productive in digital
mammography."
A partial list of features for the MultiSync MD215MG includes:
-
21"
(21.3" VIS) IPS panel
- Factory calibrated to the DICOM
grayscale function for luminance
- 2560 x 2048 native resolution
- 1100 cd/m² brightness (500 cd/m²
calibrated)
- Factory adjusted uniformity
control provides accurate imaging across the screen
- Built-in front sensor ensures
stable calibrated brightness for the life of the display
- Built-in ambient light sensor
automatically adjusts the display's brightness based on existing
lighting conditions, reducing energy consumption
- 11.9-bit internal LUT with 256
levels of gray
- DVI-D input and USB hub
- Protective panel prevents
accidental damage to the screen
- Medical certifications, including
CE-MDD 93/42/EC, Ul60601-1 and FDA 510(k) clearance for mammography
- Restriction on Hazardous
Substances (RoHS) compliant
- Five-year limited warranty with
Advanced Overnight Exchange
The MD215MG is
available at an estimated street price of $13,799, which includes the
MDCHROMA5 sensor for use with GammaCompMD™ QA quality assurance
software. The display ships with a 5-years parts and labor warranty with
Advanced Overnight Exchange, which is one of the best warranties in the
industry. |