(32 days)
RADIFORCE GX240; K120407
Not Found
No
The description focuses on display characteristics and basic automatic adjustments based on ambient conditions, not complex pattern recognition or learning algorithms.
No
The device is a monitor intended for displaying digital images, not for providing therapy.
No
The device is a display monitor for digital images and explicitly states it "does not support the display of mammography images for diagnosis." It presents images for medical practitioners but does not perform the diagnostic function itself.
No
The device description explicitly lists hardware components such as an LCD Panel, motherboard, Power Adapter, and Data Cable, in addition to the software.
Based on the provided information, the JUSHA-M23C LCD Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to display digital images for trained medical practitioners. This is a display function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the technical specifications of the monitor (resolution, luminance, grayscale, etc.) and its components. It does not mention any reagents, assays, or procedures for analyzing biological specimens.
- Mentions image processing: While it mentions "image processing," this is in the context of displaying medical images, not processing biological samples for diagnostic information. The referenced regulation (21CFR 892.2050) is for "Picture archiving and communications system," which is related to medical imaging, not IVD.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the display's technical characteristics (luminance, contrast, stability) and electrical safety/EMC, not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The JUSHA-M23C LCD Monitor's function is to display images generated by other medical devices (like X-ray machines, CT scanners, etc.), not to perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
JUSHA-M23C LCD Monitor is intended to be used in displaying digital images by trained medical practitioners. JUSHA-M23C LCD Monitor does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
JUSHA-M23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance (1000cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M23C 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, Mono-TFT LCD Panel
- JUSHA- SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-M23C 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
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:
Bench testing was conducted to demonstrate the JUSHA-M23C 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-M23C. 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-M23C, does not require animal or clinical studies to support substantial equivalence.
Key results:
JUSHA-M23C 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-M23C Medical Display does not raise any new issues of safety or effectiveness.
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.
RADIFORCE GX240; K120407
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Nanjing Jusha Display Technology Co., Ltd. % Mr. Ma Jing Certifical Engineer 301 Hanzhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing, 210036 CHINA
Re: K151238
Trade/Device Name: JUSHA-M23C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 16, 2015 Received: May 11, 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 A Ochs
Robert Ochs. Ph.D. Acting 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) K151238
Device Name JUSHA-M23C LCD monitor
Indications for Use (Describe)
JUSHA-M23C LCD Monitor is intended to be used in displaying digital images by trained medical practitioners. JUSHA-M23C LCD Monitor 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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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 6, 2015 | |
|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd | |
| Add: 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301, Hanzhongmen street, Nanjing, China. | ||
| Contact Person: | Ma Jing | |
| Certification Engineer | ||
| Nanjing Jusha Display Technology Co., Ltd | ||
| Tel: +86-25- 83305050 | ||
| Fax: +86-25- 58783271 | ||
| Device Trade Name: | JUSHA-M23C LCD Monitor | |
| Common/Usual Name: | 2MP Monochrome LCD Monitor | |
| Classification Name: Product Code: | System, image processing 21CFR 892.2050 | |
| PGY | ||
| Predicate Device(s): | RADIFORCE GX240; K120407 | |
| Device Description: | JUSHA-M23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance (1000cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M23C 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, Mono-TFT LCD Panel
- JUSHA- SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-M23C 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-M23C LCD Monitor is intended to be used in displaying and
viewing digital images by trained medical practitioners.
JUSHA-M23C LCD Monitor does not support the display of
mammography images for diagnosis. | |
| Technology: | JUSHA-M23C 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 (1000
cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,
10 DICOM look up table and 3 GAMMA look up table inside.
JUSHA-M23C 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-M23C is substantially equivalent to RADIFORCE GX240.
JUSHA-M23C employs the maximum resolution values same as that
of RADIFORCE GX240. Comparison table of the principal
characteristics of 2 devices is shown in the Attachment 1.
Attachment 1 | |
| | 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-M23C LCD Monitor to be as safe, as effective, and | |
| | performance is substantially equivalent to the predicate device(s). | |
4
5
6
This comparison identifies the similarities and differences of the proposed JUSHA-M23C LCD Monitor device to the legally marketed predicate EIZO RADIFORCE GX240 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| Display Performance/Specifications | ||
| Screen technology | 21.3" Monochrome TFT | |
| LCD Panel | 21.3" Monochrome TFT | |
| LCD Panel | ||
| Viewing angle (H, V) | Horizontal 176 °,Vertical | |
| 176 ° | Horizontal 176 °,Vertical | |
| 176 ° | ||
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31 | 52 |
| Recommended Luminance | 500cd/m² | 500cd/m² |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port) : 1024 | |
| 8-bit: 256 | 12-bit:4096 | |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided |
| Input signals | DVI standard 1.0, | |
| DisplayPort 1.1a | DVI standard 1.0, | |
| DisplayPort 1.1a | ||
| Input terminational | DVI-D (dual link) x 1, | |
| DisplayPort x 1 | DVI-D (dual link) x 1, | |
| DisplayPort x 1 | ||
| Display controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Attributes | Predicate Device | Proposed Device |
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| Power | ||
| Consumption/Save Mode | 36W/less than1.6W | 45W/less than 3W |
| Power | ||
| Management | DVI DMPM | |
| DisplayPort 1.1a | DVI DMPM | |
| DisplayPort 1.1a | ||
| USB | ||
| Ports/standard | 1 upstream (endpoint), | |
| 2 downstream/ Rev. 2.0 | 1 upstream (endpoint), | |
| 2 downstream/ Rev. 2.0 | ||
| Dimensions w/o | ||
| stand | ||
| (W x H x D) | Without stand: | |
| 376mmx505mmx98mm | ||
| With stand: | ||
| 376mmx599mmx245.5 mm | Without stand: | |
| 382mm x490mm x75mm | ||
| With stand: | ||
| 382mm x533mm x238mm | ||
| Indication for | ||
| use | RADIFORCE GX240 is | |
| intended to be used in | ||
| displaying and viewing | ||
| digital images by trained | ||
| medical practitioners. | ||
| RADIFORCE GX240 | ||
| Monitor does not support the | ||
| display of mammography | ||
| images for diagnosis. | JUSHA-M23C LCD Monitor | |
| is intended to be used in | ||
| displaying and viewing | ||
| digital images by trained | ||
| medical practitioners. | ||
| JUSHA-M23C LCD Monitor | ||
| does not support the display | ||
| of mammography images for | ||
| diagnosis. | ||
| Attributes | Predicate Device | Proposed Device |
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| 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) | 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. | 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. |
7
8
9
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-M23C 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-M23C. 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-M23C, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-M23C 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-M23C Medical Display does not raise any new issues of safety or effectiveness.