Search Results
Found 2 results
510(k) Data Aggregation
K Number
K241499Device Name
21.3 5MP Color LCD Display UMD5-21B01
Manufacturer
ACULA Technology Corp.
Date Cleared
2024-06-13
(16 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ACULA Technology Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Device Description
UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of UMD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Manage is a PC application for managing a group of displays.
Ask a Question
K Number
K233336Device Name
21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
Manufacturer
ACULA Technology Corp
Date Cleared
2024-05-21
(235 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ACULA Technology Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Device Description
UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of MD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Mange is a PC application for managing a group of displays.
Ask a Question
Page 1 of 1