(43 days)
Not Found
No
The description focuses on display technology and calibration features, with no mention of AI/ML algorithms for image analysis or interpretation.
No.
This device is a medical image display monitor used for viewing and diagnosing digital images, not for providing therapy.
Yes.
The "Intended Use / Indications for Use" states that the device is "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners" and "for review, analysis, and diagnosis by trained medical practitioners."
No
The device description explicitly lists multiple hardware components, including an LCD panel, main board, graphic card, power supply, and various cables, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a monitor for displaying and viewing digital images from modalities like X-ray, MRI, and mammography for diagnosis by trained medical practitioners. This is a display device for medical images, not a device that performs tests on biological samples.
- Device Description: The description details the components of a monitor (LCD panel, main board, software, cables, etc.). It does not mention any components related to collecting, processing, or analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Measurement of biomarkers or analytes
- Diagnostic tests performed on samples
The device is a medical image display system, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
C350G/C350/JUSHA-C350G/JUSHA-C350 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 is not specified for digital mammography system.
M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
C350G LCD Monitor is the display system with the high resolution (2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C350G has ambient brightness adapting, real-time DICOM automatic calibration 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:
- 21.3" Color TFT LCD Panel
- DMX3304AR2/main board
- C350G LCD Monitor software
- a graphic card
- a graphic card driver CD
- a CGA software CD
- an AC power cord
- an external power supply
- a DVI cable
- a DP cable
- a USB cable
M550G LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, M550G has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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: - 21.3" Mono-TFT LCD Panel - DMX3304AR2/main board - M550G LCD Monitor software - a graphic card - a graphic card driver CD - an AC power cord - an external power supply - a DVI cable - a DP cable - a USB cable In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the C350G and M550G LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. The software doesn't include any functions of image manipulation. The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - - Part 1: General requirements for basic safety and essential performance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI, standard and multi-frame digital mammography, breast tomosynthesis applications.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate the C350G LCD Monitor and M550G LCD Monitor meet 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) testing were conducted on the C350G LCD Monitor and M550G LCD Monitor. 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, C350G LCD Monitor and M550G LCD Monitor, do not require animal or clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
C270G;K183498, BARCO MDMG-5221; K161229
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301, Hanzhongmen street Naniing, Jiangsu 210036 CHINA
June 7, 2023
Re: K231170
Trade/Device Name: C350/C350G LCD Monitor: M550/M550G LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 25, 2023 Received: April 25, 2023
Dear Donny Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, PhD. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231170
Device Name C350/C350G LCD Monitor M550/M550G LCD Monitor
Indications for Use (Describe)
C350G/C350/JUSHA-C350G/JUSHA-C350 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 is not specified for digital mammography system.
M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
(K231170)
1. In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Apr 16, 2023 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 8A, Block 1. Nanjing International Service Outsourcing | |
| Mansion, No. 301, Hanzhongmen street, Nanjing City, Jiangsu | |
| Province, 210036 China. | |
| Contact Person: | Donny Lee |
| Certification Engineer | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783273 | |
| Device Trade Name: | C350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCD |
| Monitor, JUSHA-C350 LCD Monitor (There is no difference between | |
| C350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCD | |
| Monitor and JUSHA-C350 LCD Monitor except for labeling as they | |
| are marketed in different areas. It does not affect their safety or | |
| effectiveness in any terms. ) | |
| M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550G LCD | |
| Monitor, JUSHA-M550 LCD Monitor (There is no difference | |
| between M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550G | |
| LCD Monitor and JUSHA-M550 LCD Monitor except for labeling as | |
| they are marketed in different areas. It does not affect their safety or | |
| effectiveness in any terms. ) | |
| Common/Usual Name: | 3MP LCD Monitor and 5MP LCD Monitor |
| Classification Name: | Medical Image Management and Processing System, 21 CFR |
| 892.2050 | |
| Product Code: | PGY |
| Device Class: | Class II |
4
| Predicate Device(s): | C270G;K183498
BARCO MDMG-5221; K161229 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Medical Image Management and Processing System, 21 CFR
892.2050 |
| Product Code: | PGY |
| Device Class: | Class II |
| Device Description: | C350G LCD Monitor is the display system with the high resolution
(2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors,
built-in DICOM standard LUT. In particular, C350G has ambient
brightness adapting, real-time DICOM automatic calibration 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:
- 21.3" Color TFT LCD Panel
- DMX3304AR2/main board
- C350G LCD Monitor software
- a graphic card
- a graphic card driver CD
- a CGA software CD
- an AC power cord
- an external power supply
- a DVI cable
- a DP cable
- a USB cable
M550G LCD Monitor is the display system with the high resolution
(2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale
(65536 level), built-in DICOM standard LUT. In particular, M550G |
5
has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, fullscreen brightness equalization 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: - 21.3" Mono-TFT LCD Panel - DMX3304AR2/main board - M550G LCD Monitor software - a graphic card - a graphic card driver CD - an AC power cord - an external power supply - a DVI cable - a DP cable - a USB cable In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the C350G and M550G LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. The software doesn't include any functions of image manipulation. The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - - Part 1: General requirements for basic safety and essential performance.
6
| 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic disturbances -
| Requirements and tests. | |
|---|---|
| Intended Use: | C350G/C350/JUSHA-C350G/JUSHA-C350 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 is not | |
| specified for digital mammography system. |
M550G/M550/JUSHA-M550G/JUSHA-M550 LCD Monitor is
intended to be used in displaying and viewing digital images, including
standard and multi-frame digital mammography, for review, analysis,
and diagnosis by trained medical practitioners. It is specially de
displaying and viewing digital images, including standard and multi-
frame digital mammography, for review, analysis, and diagnosis by
trained medical practitioners. It is specially designed for breast
tomosynthesis applications. |
| Technology: | C350G LCD Monitor is the display system with the high resolution
(2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors,
built-in DICOM standard LUT. In particular, C350G LCD Monitor has
ambient brightness adapting, real-time DICOM automatic calibration
and presence induction system, with these this display can automatic
adjustment according to different requirements in order to achieve the
best results.
M550G LCD Monitor is the display system with the high resolution
(2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale
(65536 level), built-in DICOM standard LUT. In particular,
M550G/M550 LCD Monitor has ambient brightness adapt inside. In
particular, M550G LCD Monitor has ambient brightness adapting, real-
time DICOM automatic calibration, full-screen brightness equalization
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 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-
1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical equipment medical electrical equipment
- Part 1: General requirements for basic safety and essential
performance |
| 2 | IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical
electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests
C350G LCD Monitor is substantially equivalent to C270G. M550G
LCD Monitor is substantially equivalent to BARCO MDMG-5221.
They have equivalent characteristics and functions according to
comparison table, please refer to 2. Product Comparison
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 devices are Substantially Equivalent (SE) to the
predicate devices which is US legally market device. Therefore, the
subject devices are determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the C350G
LCD Monitor and M550G LCD Monitor to be as safe, as effective,
and performance are substantially equivalent to the predicate
device(s). |
7
2. Product Comparison
2. 1 C350G and its predicate device comparison
This comparison identifies the similarities and differences of the proposed C350G LCD monitor device to the legally marketed predicate C270G LCD Monitor device to which substantial equivalency is claimed.
8
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| | | Display Performance/Specifications | |
| Screen
technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle
(H, V) | Horizontal 178°, Vertical
178° | Horizontal 178°, Vertical
178° | Same |
| Resolution | 1600 x 1200/1200 x 1600 | 2048x 1536 | C350G has a
higher resolution
than C270G
Image quality is
better than the
image displayed
on the predicate
device. |
| Display area | 432.0 (H) x 324.0(V) mm | 433.15(H) x324.86(V) mm | - |
| Contrast Ratio | 1400:1 | 1500:1 | C350G has a
higher contrast
ratio than C270G
Image quality is
better than the
image displayed
on the predicate
device. |
| DICOM
calibrated
luminance | 350cd/m² | Max:800cd/m²
Recommend:500cd/m² | C350G has a
higher calibrated
luminance than
C270G
Image quality is
better than the
image displayed
on the predicate
device. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Pixel Pitch | 0.27x0.27 mm | 0.2115x0.2115 mm | C350G has a
smaller pixel
pitch than
C270G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | same |
| Scanning
frequency (H; V) | 37.975kHz;60Hz | 74.297.68kHz;60Hz | - |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Input | | | |
| Input signals | DVI standard 1.0,
DisplayPort 1.2a | DVI standard 1.0,
DisplayPort 1.2a | Same |
| Input
terminational | DVI-D x 1,
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| Terminational
Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | DC 24V | DC 24V | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Power
Consumption/Sa
ve Mode | 50W/less than 0.5W | 90W/less than 0.5W | The differences
caused by
components used
in the LCD
Monitor. This
only shows the
power
consumption is
different,
nothing to do
with the display
function |
| Power
Management | DVI DMPM
Display Port 1.1a | DVI DMPM
Display Port 1.2a | 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:
382mm x490mm x77mm
With stand:
382mm x635mm x238mm | Without stand:
382mm x490mm x77mm
With stand:
363mm x(530-635)mm
x238mm | Different
housing design
due to the
different panel
size. |
| Indication for
use | C270G 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. | C350G 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 is not specified
for digital mammography
system. | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Applicable
standard | IEC 60601-1:2012, EN
60601-1:2013, ANSI/AAMI
ES60601-
1:2005+A1:2012+C1:2009+
A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
IEC 60601-1-2 Edition
4:2014, EN 60601-1-2:2015,
Medical electrical equipment
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic disturbances
- Requirements and tests | IEC 60601-1:2012, EN
60601-1:2013, ANSI/AAMI
ES60601-
1:2005+A1:2012+C1:2009+
A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
IEC 60601-1-2 Edition
4:2014, EN 60601-1-2:2015,
Medical electrical equipment
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic disturbances - Requirements and tests | Same |
9
10
11
2.2 M550G and its predicate device comparison
This comparison identifies the similarities and differences of the proposed M550G LCD monitor device to the legally marketed predicate BARCO MDMG-5221 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
|---|---|---|---|
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Display Performance/Specifications | |||
| Screen technology | 21.3inches, Mono-TFT LCD Panel | 21.3inches, Mono-TFT LCD Panel | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of |
| Differences | |||
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Viewing angle | |||
| (H, V) | Horizontal 176 °,Vertical | ||
| 176 ° | Horizontal 178 °,Vertical | ||
| 178 ° | |||
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x377.92(V) mm | |
| Contrast Ratio | 950:1 | 2000:1 | M550G has a |
| higher contrast | |||
| ratio than | |||
| MDMG5221 | |||
| Image quality is | |||
| better than the | |||
| image displayed | |||
| on the predicate | |||
| device. | |||
| DICOM | |||
| calibrated | |||
| luminance | 1000cd/m2 | Max: 1000cd/m² | |
| Recommended:500cd/m2 | Same | ||
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same. |
| DICOM LUT | 10-bit:1024 | 16-bit:65536 | The JUSHA- |
| M550G LCD | |||
| Monitor uses a | |||
| color bit | |||
| expansion | |||
| technology to | |||
| improve image | |||
| display quality, | |||
| the image clarity | |||
| is better than the | |||
| image displayed | |||
| on the predicate | |||
| device. | |||
| Luminance | |||
| calibration | Built in calibration sensor | ||
| provided | Built in calibration sensor | ||
| provided | Same | ||
| Video Signal Input | |||
| Attributes | Predicate Device | Proposed Device | Discussion of |
| Differences | |||
| Product | BARCO MDMG-5221 | M550G LCD Monitor | - |
| 510(k) Number | K161229 | / | - |
| Input signals | DVI standard 1.0, | ||
| DisplayPort 1.2a | DVI standard 1.0, | ||
| DisplayPort 1.2a | Same | ||
| Input | |||
| terminational | DVI-D x 1, | ||
| DisplayPort x 1 | DVI-D x 1, | ||
| DisplayPort x 1 | Same | ||
| Output signals | - | DisplayPort 1.2a | - |
| Output | |||
| Terminational | - | DisplayPort x 1 | - |
| Display | |||
| controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| Power | |||
| Requirement | AC 100 | DC 24V | Different power |
| supply, will not | |||
| affect the | |||
| performance | |||
| Power | |||
| Consumption/Save Mode | 57W/less than 0.7W | 80W/less than 0.5W | The differences |
| caused by | |||
| components used | |||
| in the LCD | |||
| Monitor. This | |||
| only shows the | |||
| power | |||
| consumption is | |||
| different, | |||
| nothing to do | |||
| with the display | |||
| function | |||
| Power | |||
| Management | DVI DMPM | ||
| DisplayPort 1.2a | DVI DMPM | ||
| DisplayPort 1.2a | Same | ||
| Miscellaneous Features/Specifications | |||
| USB | |||
| Ports/standard | 1 upstream (endpoint), | ||
| 2 downstream/ Rev. 2.0 | 1 upstream (endpoint), | ||
| 2 downstream/ Rev. 2.0 | Same | ||
| Attributes | Predicate Device | Proposed Device | Discussion of |
| Differences | |||
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Dimensions w/o | |||
| stand | |||
| (W x H x D) | Without stand: | ||
| 392mm x484mm x122mm | |||
| With stand: | |||
| 780mm x550mm x261mm | Without stand: | ||
| 368mm x474mm x70mm | |||
| With stand: | |||
| 368mm x(521-631)mm x238mm | Different | ||
| housing design | |||
| due to the | |||
| different panel | |||
| size. | |||
| Indication for | |||
| use | BARCO MDMG-5221 | ||
| device intended to be used in | |||
| displaying and viewing | |||
| digital images, including | |||
| standard and multi-frame | |||
| digital mammography, for | |||
| review, analysis, and | |||
| diagnosis by trained medical | |||
| practitioners. It is specially | |||
| de displaying and viewing | |||
| digital images, including | |||
| standard and multi-frame | |||
| digital mammography, for | |||
| review, analysis, and | |||
| diagnosis by trained medical | |||
| practitioners. It is specially | |||
| designed for breast | |||
| tomosynthesis applications. | M550G LCD Monitor is | ||
| intended to be used in | |||
| displaying and viewing | |||
| digital images, including | |||
| standard and multi-frame | |||
| digital mammography, for | |||
| review, analysis, and | |||
| diagnosis by trained medical | |||
| practitioners. It is specially | |||
| de displaying and viewing | |||
| digital images, including | |||
| standard and multi-frame | |||
| digital mammography, for | |||
| review, analysis, and | |||
| diagnosis by trained medical | |||
| practitioners. It is specially | |||
| designed for breast | |||
| tomosynthesis applications. | Same |
12
13
14
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| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Applicable
standard | Electrical Safety test (IEC
60601-1) | 1 IEC 60601-1:2012, EN
60601-1:2013, ANSI/AAMI
ES60601-
1:2005+A1:2012+C1:2009+
A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
2 IEC 60601-1-2 Edition
4:2014, EN 60601-1-2:2015,
CFR 47 FCC Part15 subpart
B: 2017, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
disturbances - Requirements
and tests | Same |
| | EMC test (IEC 60601-1-2) | | |
2.3 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
2.3.1 Bench testing:
Bench testing was conducted to demonstrate the C350G LCD Monitor and M550G LCD Monitor meet 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
16
2.3.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the C350G LCD Monitor and M550G LCD Monitor. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
2.3.3 Animal and clinical study
The subject of this premarket submission, C350G LCD Monitor and M550G LCD Monitor, do not require animal or clinical studies to support substantial equivalence.
2.4 CONCLUSIONS
C350G LCD Monitor and M550G LCD Monitor are substantially equivalent to the predicate devices 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 C350G LCD Monitor and M550G LCD Monitor do not raise any new issues of safety or effectiveness.