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Found 6 results
510(k) Data Aggregation
K Number
K241105Device Name
3MP Color LCD Monitor (CL-S301)
Manufacturer
Jvckenwood Corporation
Date Cleared
2024-08-01
(101 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Jvckenwood Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-S301 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Device Description
21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
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K Number
K222864Device Name
8MP Color LCD Monitor CL-R813
Manufacturer
JVCKENWOOD Corporation
Date Cleared
2022-12-21
(90 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVCKENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
Device Description
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- Color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.
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K Number
K212985Device Name
6MP Color LCD Monitor CL-S600
Manufacturer
JVCKENWOOD Corporation
Date Cleared
2021-12-16
(90 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVCKENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Device Description
30 inch Color LCD Monitor 3280 x 2080 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
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K Number
K203733Device Name
12MP Color Digital Mammography LCD Monitor CL-S1200
Manufacturer
JVCKENWOOD Corporation
Date Cleared
2021-06-29
(190 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVCKENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Device Description
30.9 inch Color Digital Mammography LCD Monitor 4200 x 2800 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display including mammography.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
A glass filter protects the surface of the LCD panel.
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K Number
K210345Device Name
2MP Monochrome LCD Monitor MS-S200
Manufacturer
Jvckenwood Corporation
Date Cleared
2021-04-23
(77 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Jvckenwood Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MS-S200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Device Description
21.3 inch (54cm) Monochrome LCD Monitor
1600 x1200 (landscape)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
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K Number
K200161Device Name
3MP Monochrome Digital Mammography LCD Monitor MS-S300
Manufacturer
Jvckenwood Corporation
Date Cleared
2020-02-21
(30 days)
Product Code
PGY, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Jvckenwood Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MS-S300 is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Device Description
21.3 inch Monochrome Digital Mammography LCD Monitor
2048 x 1536 (landscape), 1536 x 2048 (portrait)
■ High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
■ Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
■ Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
■ It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
■ Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
Ask a Question
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