(39 days)
Not Found
No
The description focuses on display technology, resolution, luminance, and compliance with electrical and safety standards. While it has "automatic" functions (identifying signals, adjusting brightness), these appear to be rule-based or sensor-driven automation, not AI/ML. There is no mention of learning, training data, or complex pattern recognition characteristic of AI/ML.
No
The device is an LCD monitor used for displaying digital images for review and analysis by medical practitioners; it does not perform any therapeutic function.
No
The device is a monitor used to display digital images for review and analysis by medical practitioners; it does not perform diagnostic functions itself.
No
The device description explicitly lists hardware components such as an LCD display, motherboard, power adapter, and data cable, in addition to software.
Based on the provided information, the JUSHA-C61 LCD Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "displaying digital images for review and analysis by trained medical practitioners." This describes a display device for medical images, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the technical specifications of a display monitor (resolution, luminance, color depth, LUTs, etc.). It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Reagents or assays
- Sample handling or analysis
- Measurement of biological markers
- Diagnostic algorithms based on biological data
The device is clearly a medical display intended for viewing medical images, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
JUSHA-C61 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes
PGY
Device Description
JUSHA-C61 LCD Monitor is the display system with the high resolution (3280*2048), high luminance (700cd/m^2 ), 10 bit display colors expanded to 12 bit color expansion technology, 7 DICOM look up table and one GAMMA2.2 look up table inside. In particular, JUSHA-C61 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-C61 LCD Monitor 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:
- 30.0 inch, a-Si TFT Liquid Crystal Display
- JUSHA-C61 motherboard/FR-4/REV:2.0
- JUSHA-C61 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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:
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.
JUSHA-C61 is substantially equivalent to EIZO RX650. JUSHA- C61 employs the maximum resolution values same as that of EIZO RX650. 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)
EIZO RX650;K134002
Reference Device(s)
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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
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: K141679
Trade/Device Name: Jusha-C61 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
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,
FDA
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)
K141679
Device Name
JUSHA-C61 LCD Monitor
Indications for Use (Describe)
JUSHA-C61 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It 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)
Smh.7)
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-C61 LCD Monitor |
| Common/Usual Name: | 6MP Color LCD Monitor |
| Classification Name: Product Code: | Display, Diagnostic Radiology 21CFR 892.2050 |
| PGY | |
| Predicate Device(s): | EIZO RX650;K134002 |
| Device Description: | JUSHA-C61 LCD Monitor is the display system with the high |
| resolution (3280*2048), high luminance ( $700cd/m^2$ ), 10 bit display | |
| colors expanded to 12 bit color expansion technology, 7 DICOM look | |
| up table and one GAMMA2.2 look up table inside. In particular, | |
| JUSHA-C61 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-C61 LCD Monitor 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: | |
| - 30.0 inch, a-Si TFT Liquid Crystal Display | |
| - JUSHA-C61 motherboard/FR-4/REV:2.0 | |
| - JUSHA-C61 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-C61 LCD Monitor is intended to be used in displaying and |
| viewing digital images for review and analysis by trained medical | |
| practitioners. It does not support the display of mammography images | |
| for diagnosis. | |
| Technology: | JUSHA-C61 LCD Monitor is the display system with the high |
| resolution (3280*2048) with electronic capabilities for evaluation of | |
| high resolution medical images, high luminance (700cd/m²), 10 bit | |
| display colors expanded to 12 bit color expansion technology, 7 | |
| DICOM look up table and one GAMMA2.2 look up table inside. In | |
| particular, JUSHA-C61 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-C61 LCD Monitor 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: | |
| 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. | |
| JUSHA-C61 is substantially equivalent to EIZO RX650. JUSHA- | |
| C61 employs the maximum resolution values same as that of EIZO | |
| RX650. 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. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA- |
| C61 LCD Monitor to be as safe, as effective, and performance is | |
| substantially equivalent to the predicate device(s). |
4
5
510(k) Premarket Notification Submission
Attachment 1:
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | EIZO RX650 | JUSHA-C61 LCD Monitor |
| 510(k) Number | K134002 | K141679 |
| Screen technology | 30.0" Color TFT LCD Panel | 30.0" Color TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 176°, Vertical 176° | Horizontal 170°, Vertical 170° |
| Resolution | 2048 x 3280/3280x 2048 | 2048 x 3280/3280x 2048 |
| Display area | 645.5(H) x 403.0 (V) mm | 645.5 (H) x 403.0 (V) mm |
| Contrast Ratio | 1000:1 | 1000:1 |
| Recommended | ||
| Luminance | 400cd/m² | 400cd/m² |
| Pixel Pitch | 0.197x0.197 mm | 0.197x0.197 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 x2 | |
| Display Port x2 | DVI-D Dual Link x2 | |
| Display Port x2 | ||
| Display controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
6
| 510(k) Premarket Notification Submission |
|---|
| Power
Consumption/Save
| Mode | 108W/less than 6W | 100W/less than 1.5W |
|---|---|---|
| Power Management | DVI DMPM | 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: | |
| 692mmx466mmx109 mm With | ||
| stand: | ||
| 692mmx478~643mmx302 mm | Without stand: | |
| 704mm x 478mm x 81mm | ||
| With stand: | ||
| 704mm x 611mm x292mm | ||
| 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. |