(64 days)
Not Found
No
The device description focuses on standard display technology features and compliance with electrical and safety standards. The "ambient brightness adapting and presence induction system" is described as an "automatic adjustment" based on requirements, which is more indicative of rule-based or sensor-driven automation rather than AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an LCD monitor intended for displaying digital images for diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners."
No
The device description explicitly lists hardware components such as an LCD Panel, motherboard, power adapter, and data cable, in addition to software.
Based on the provided information, the JUSHA-C23C LCD Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to display digital images for diagnosis of X-ray or MRI, etc. This involves displaying images generated from within the patient's body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on the technical specifications of the display itself (resolution, luminance, look-up tables, etc.) and its components. It does not mention any reagents, calibrators, controls, or other elements typically associated with IVD devices used for analyzing biological samples.
- Standards: The device is designed and tested according to standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2), which are relevant to the safety and performance of electrical devices used in a medical setting, but not specifically for IVD devices.
- Performance Studies: The performance studies described focus on the display characteristics (luminance, uniformity, contrast, temporal response, stability) and electrical safety/EMC. These are relevant to the quality of the image display, not the analytical performance of an IVD test.
In summary, the JUSHA-C23C LCD Monitor is a medical device used for displaying medical images, but it does not perform any diagnostic testing on samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
JUSHA-C23C LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Product codes
PGY
Device Description
JUSHA-C23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance 600cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table and 3 GAMMA look up table inside. JUSHA-C23C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 21.3inches, Color-TFT LCD Panel
- JUSHA-SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-C23C LCD Monitor software
- Power Adapter
- Data Cable
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)
- IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Mentions image processing
System, image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was conducted to demonstrate the JUSHA-C23C meets all performance standards as follows:
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio.
- Measurement of temporal response
- Performance data on luminance stability
Electrical safety and EMC testing were conducted on the JUSHA-C23C The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject of this premarket submission, JUSHA-C23C, does not require animal or clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
RADIFORCE RX240; K113844
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Nanjing Jusha Display Technology Co., Ltd. % Ma Jing Certification Engineer 301 Hnazhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing Jiangsu 210036 CHINA
Re: K151861
Trade/Device Name: JUSHA-C23C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 13, 2015 Received: August 17, 2015
Dear Ma Jing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151861
Device Name JUSHA-C23C LCD Monitor
Indications for Use (Describe)
JUSHA-C23C LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 6, 2014 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Ma Jing |
| Certification Engineer | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Add: 8A, Block 1. Nanjing International Service Outsourcing | |
| Mansion, No. 301, Hanzhongmen street, Nanjing, China. | |
| Fax: +86-25- 58783271 | |
| Device Trade Name: | JUSHA-C23C LCD Monitor |
| Common/Usual Name: | 2MP Color LCD Monitor |
| Classification Name: Product | System, image processing 21CFR 892.2050 |
| Code: | PGY |
| Predicate Device(s): | RADIFORCE RX240; K113844 |
| Device Description: | JUSHA-C23C LCD Monitor is the display system with the high |
| resolution (1600*1200), high luminance 600cd/m²), and 1024 | |
| simultaneous shades of gray out of a palette of 4096, 8 DICOM look | |
| up table and 3 GAMMA look up table inside. JUSHA-C23C has | |
| ambient brightness adapting and presence induction system, with | |
| these this display can automatic adjustment according to different | |
| requirements in order to achieve the best results. | |
| The product is consisted of the following components: | |
| - 21.3inches, Color-TFT LCD Panel | |
| - JUSHA-SMS_19inch motherboard/FR-4/REV:0.1 | |
| - JUSHA-C23C LCD Monitor software | |
| - Power Adapter | |
| - Data Cable | |
| The LCD Monitor is designed, tested, and will be manufactured in | |
| accordance with both mandatory and voluntary standards: |
- IEC 60601-1Medical equipment medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
2005+CORR.1(2006)+CORR.2(2007) - IEC 60601-1-2 Edition 3:2007, Medical electrical
equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests. |
| Intended Use: | JUSHA-C23C LCD Monitor is intended to be used in displaying and
viewing digital images for diagnosis of X-ray or MRI, etc. by trained
medical practitioners. The device does not support the display of
mammography images for diagnosis. |
| Technology: | JUSHA-C23C LCD Monitor is the display system with the high
resolution monitor (2 megapixels) with electronic capabilities for
evaluation of high resolution medical images, high luminance (600
cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,
8 DICOM look up table and 3 GAMMA look up table inside. In
particular, JUSHA-C23C LCD Monitor contains CGA function, it is
specially made by JUSHA, it can automatic identify gray and color
signals, then gray area calls DICOM LUT and color area calls
GAMMA2.2 LUT. JUSHA-C23C has ambient brightness adapting
and presence induction system, with these this display can automatic
adjustment according to different requirements in order to achieve the
best results. |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor complies with voluntary standards as following:
1 IEC 60601-1Medical equipment medical electrical equipment -
Part 1: General requirements for basic safety and essential
performance 2005+CORR.1(2006)+CORR.2(2007)
2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility
- Requirements and tests.
JUSHA-C23C is substantially equivalent to RADIFORCE RX240.
JUSHA-C23C employs the maximum resolution values same as that
of RADIFORCE RX240. Comparison table of the principal
characteristics of 2 devices is shown in the Attachment 1 |
| | Attachment 1 |
| | The following quality assurance measures were applied to the |
| | development of the system: |
| | • Risk Analysis |
| | • Requirements Reviews |
| | • Design Reviews |
| | • Raw materials verification |
| | • Testing on unit level (Module verification) |
| | • Integration testing (System verification) |
| | • Final acceptance testing (Validation) |
| | • Performance testing (Verification) |
| | • Safety testing (Verification) |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, LCD Monitor, did not |
| | require clinical studies to support substantial equivalence. |
| | The proposed device is Substantially Equivalent (SE) to the predicate |
| | device which is US legally market device. Therefore, the subject |
| | device is determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the |
| | JUSHA-C23C LCD Monitor to be as safe, as effective, and |
| | performance is substantially equivalent to the predicate device(s). |
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12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-C23C LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX240 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | | | |
| | | | Display Performance/Specifications | |
| Screen
technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same | |
| Viewing angle
(H, V) | Horizontal 176° ;Vertical
176° | Horizontal 176° ;Vertical
176° | Same | |
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 | Same | |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm | Same | |
| Contrast Ratio | 1200:1 | 1400:1 | Due to the
different panel. | |
| Scanning
frequency (H; V) | 31100 kHz;5961Hz | 5276 kHz;5961Hz | This difference
between the two
device is caused
by the different
no display area
defined by
different
manufacturers,
nothing to do
with the display
function. | |
| Recommended
Luminance | 400cd/m² | 400cd/m² | Same | |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same. | |
| Backlight | LED | LED | Same | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | / | | |
| DICOM LUT | 10-bit (Display Port) : 1024 | 12-bit:4096 | The
JUSHA-C23C
LCD Monitor
uses a grayscale
expansion
technology to
improve image
display quality,
the image clarity
is better than the
image displayed
on the predicate
device. | |
| | | | | |
| | 8-bit: 256 | | | |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | | |
| | | | | |
| Video Signal Input | | | | |
| Input signals | DVI standard 1.0, | DVI standard 1.0, | | |
| | DisplayPort 1.1a | DisplayPort 1.1a | | |
| Input
terminational | DVI-D x 1, | DVI-D x 1, | | |
| | DisplayPort x 1 | DisplayPort x 1 | | |
| Display
controller | Off the shelf | Off the shelf | | |
| | | | | |
| Power Related Specification | | | | |
| Power
Requirement | AC 100240V 5060Hz | AC 100240V 5060Hz | | |
| | | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | / | | |
| Power
Consumption/Save Mode | 52W/less than1.6W | 65W/less than 2.5W | The differences
caused by
different adapter
and components
used in the LCD
Monitor, the
JUSHA-C23C
has more power
consumption.
This only shows
the power
consumption is
different,
nothing to do
with the display
function | |
| Power
Management | DVI DMPM
DisplayPort 1.1a | DVI DMPM
DisplayPort 1.1a | Same | |
| Miscellaneous Features/Specifications | | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | Same | |
| Dimensions w/o
stand
(W x H x D) | Without stand:
376mmx505mmx98mm
With stand:
376mmx599mmx245.5 mm | Without stand:
382mm x490mm x75mm
With stand:
382mmx533mm x238mm | Different
housing design
due to the
different panel
size. | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | / | | |
| Indication for
use | RADIFORCE RX240 is
intended to be used in
displaying and viewing
digital images for diagnosis
of X-ray or MRI, etc. by
trained medical practitioners.
The device does not
support the display of
mammography images for
diagnosis. | JUSHA-C23C LCD Monitor
is intended to be used in
displaying and viewing
digital images for diagnosis
of X-ray or MRI, etc. by
trained medical practitioners.
The device does not
support the display of
mammography images for
diagnosis. | Same | |
| Applicable
standard | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+COR
R.2(2007)
2 IEC 60601-1-2 Edition
3:2007, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests. | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+COR
R.2(2007)
2 IEC 60601-1-2 Edition
3:2007, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests. | Same | |
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PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the JUSHA-C23C meets all performance standards as follows:
- . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio.
- Measurement of temporal response
- Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JUSHA-C23C The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Animal and clinical study
The subject of this premarket submission, JUSHA-C23C, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C23C Medical Display is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-C23C Medical Display does not raise any new issues of safety or effectiveness.