(39 days)
EIZO RX340;K113562
Not Found
No
The description focuses on display technology, resolution, luminance, and compliance with electrical and safety standards. There is no mention of AI, ML, or any algorithms that perform analysis or interpretation of the medical images. The "automatic adjustment" features described relate to ambient brightness and presence detection, which are standard display functionalities, not AI/ML.
No
The device is a monitor intended for displaying diagnostic images, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the JUSHA-C33C 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." This direct statement confirms its diagnostic purpose.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images from modalities like X-ray and MRI for diagnosis. 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 for image display (resolution, luminance, color depth, LUTs, etc.). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a medical display monitor used by trained medical practitioners to view diagnostic images. While it is a medical device, its function is to present information, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
JUSHA-C33C 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.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
JUSHA-C33C LCD Monitor is the display system with the high resolution (2048*1536), high luminance (600 cd/m²), and10 bit display colors expanded to 12 bit color expansion technology, 8 DICOM look up table and 3 GAMMA look up table inside. In particular, JUSHA-C33C 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-C33C 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:
- 21.3" Color TFT LCD Panel
- JUSHA-C33/45T motherboard/FR-4/REV:0.9
- JUSHA-C33C 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 1988+A1 : 1991 + A2:1995
- 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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-C33C is substantially equivalent to EIZO RX340. JUSHA-C33C employs the maximum resolution values same as that of EIZO RX340. Comparison table of the principal characteristics of 2 devices is shown in the 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.
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.
EIZO RX340;K113562
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2014
Nanjing Jusha Display Technology Co., Ltd. % Ms. Li Le Certification Manager 8A. Block 1. Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street, Nanjing 210036 CHINA
Re: K141684
Trade/Device Name: Jusha-C33C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 24, 2014 Received: June 30, 2014
Dear Ms. Le:
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 (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.
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,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K141684
Device Name
JUSHA-C33C LCD Monitor
Indications for Use (Describe)
JUSHA-C33C 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FDA
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 | ||
| Add: 301, 8F Block A, No.1, Nanjing International Service | |||
| Outsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China | |||
| Contact Person: | Li le | ||
| Certification Manager | |||
| Nanjing Jusha Display Technology Co., Ltd | |||
| Tel: +86-25- 83305050 | |||
| Fax: +86-25- 58783271 | |||
| Device Trade Name: | JUSHA-C33C LCD Monitor | ||
| Common/Usual Name: | 3MP Color LCD Monitor | ||
| Classification Name: Product | |||
| Code: | Display, Diagnostic Radiology 21CFR 892.2050 | ||
| PGY | |||
| Predicate Device(s): | EIZO RX340;K113562 | ||
| Device Description: | JUSHA-C33C LCD Monitor is the display system with the high | ||
| resolution (2048*1536), high luminance (600 cd/m²), and10 bit | |||
| display colors expanded to 12 bit color expansion technology, 8 | |||
| DICOM look up table and 3 GAMMA look up table inside. In | |||
| particular, JUSHA-C33C 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-C33C 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: | |||
| - 21.3" Color TFT LCD Panel | |||
| - JUSHA-C33/45T motherboard/FR-4/REV:0.9 | |||
| - JUSHA-C33C 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 1988+A1 : 1991 + A2:1995 | | |
| | IEC 60601-1-2 Edition 3:2007, Medical electrical
2.
equipment - Part 1-2: General requirements for basic | | |
4
| safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. | |
|---|---|
| Intended Use: | JUSHA-C33C 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-C33C LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (600 cd/m²) and10 bit display colors expanded to 12 bit color expansion technology, 8 DICOM look up table and 3 GAMMA look up table inside. In particular, JUSHA-C33C 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-C33C 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-C33C is substantially equivalent to EIZO RX340. JUSHA-C33C employs the maximum resolution values same as that of EIZO RX340. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1. | |
| The following quality assurance measures were applied to the development of the system: | |
| Risk AnalysisRequirements ReviewsDesign ReviewsRaw materials verificationTesting 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- |
| C33C LCD Monitor to be as safe, as effective, and performance is | |
| substantially equivalent to the predicate device(s). |
5
510(k) Premarket Notification Submission
Attachment 1:
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | EIZO RX340 | JUSHA-C33C LCD Monitor |
| 510(k) Number | K113562 | K141684 |
| Screen technology | 21.2" Color TFT LCD Panel | 21.3" Color TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 176°, Vertical 176° |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 |
| Display area | 323.7 (H) x431.6 (V) mm | 324.864 (H) x 433.152 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31 | 96.7kHz;60Hz |
| Recommended Luminance | 400cd/m² | 400cd/m² |
| Pixel Pitch | 0.21075 x 0.21075 mm | 0.2115x0.2115 mm |
| Backlight | LED | LED |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit, 68.7billion colors |
| 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 |
6
| Power Consumption/Save
| Mode | 56W/less than 3W | 65W/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: | |
| 376mmx505mmx98 mm | ||
| With stand: | Without stand: | |
| 382mm x490mm x75mm With | ||
| stand: | ||
| 382mm x533mm x238mm | ||
| Applicable standard | 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 | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+CORR.2(
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 |