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K Number
K150746
Device Name
JUSHA-M52C Medical Display
Manufacturer
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
Date Cleared
2015-04-14

(22 days)

Product Code
PGY
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.
Device Description
JUSHA-M52C Medical Display is the display system with the high resolution(2048 x 2560), high luminance(700 cd/m² ), and 256 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table inside, the product is consisted of the following components: - 21.3 inch, mono-TFT Liquid Crystal Display - Motherboard HDVI-3M V1.0 - JUSHA-M52C Medical Display software - Power Adapter - Data Cable.
More Information

K131390

Not Found

No
The device description and intended use focus solely on the display capabilities and hardware components, with no mention of AI or ML algorithms for image analysis or processing beyond standard display functions.

No
The device is a medical display used for viewing images, not for treating conditions.

No

Explanation: A diagnostic device would analyze medical images or data to generate a diagnosis or aid in diagnosis. This device is a display system that shows medical images but does not perform any analysis or interpretation itself.

No

The device description explicitly lists hardware components such as a Liquid Crystal Display, Motherboard, Power Adapter, and Data Cable, in addition to the software.

Based on the provided information, the JUSHA-M52C Medical Display is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images". This describes a device used to visualize existing medical images, not a device that performs tests on biological samples to diagnose conditions.
  • Device Description: The description details a display system with specific technical specifications for image presentation (resolution, luminance, grayscale, DICOM support). It does not mention any components or functionalities related to analyzing biological samples or performing diagnostic tests on them.
  • Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or other methods for analyzing biological specimens (blood, urine, tissue, etc.) to provide diagnostic information. This device is purely for displaying images.

The device is a medical display intended for the visualization of medical images, which falls under a different regulatory category than IVD devices.

N/A

Intended Use / Indications for Use

JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.

Product codes (comma separated list FDA assigned to the subject device)

PGY, 90LLZ

Device Description

JUSHA-M52C Medical Display is the display system with the high resolution(2048 x 2560), high luminance(700 cd/m² ), and 256 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table inside, the product is consisted of the following components:

  • 21.3 inch, mono-TFT Liquid Crystal Display
  • Motherboard HDVI-3M V1.0
  • JUSHA-M52C Medical Display software
  • Power Adapter
  • Data Cable.
    The Medical Display is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
  1. IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ EN 60601-1: 2006/AC: 2010
  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.

Mentions image processing

System, image processing

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 Medical Display complies with voluntary standards as following:
1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/

EN 60601-1: 2006/AC: 2010

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-M52C is substantially equivalent to RadiForce G51. G51. M52C employs the maximum resolution values same as that of RadiForce G51. Comparison table of the principal Characteristics of 2 devices is shown in the Attachment 1 .
Attachment 1
The following quality assurance measures were applied to the development of the system:
• Risk Analysis
• Requirements Reviews
•Design Reviews
•Raw materials verification
•Testing on unit level (Module verification)
•Integration testing (System verification)
•Final acceptance testing (Validation)
•Performance testing (Verification)
•Safety testing (Verification)

Summary of Clinical Tests:
The subject of this premarket submission, Medical Display, 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.

JUSHA-M52C;K131390

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" 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

April 14, 2015

Nanjing Jusha Display Technology Co., LTD % Mr. Ma Jing Certification Engineer 301 Hanzhongmen Street, 8F Block A. No.1 Nanjing International Service Outsourcing MANSION, NANJING 210036 CHINA

Re: K150746

Trade/Device Name: JUSHA-M52C Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 16, 2015 Received: March 23, 2015

Dear Mr. 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, PhD. 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) K150746

Device Name JUSHA-M52C Medical Display

Indications for Use (Describe)

JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.

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

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:July 21,2013
Submitter:Nanjing Jusha Display Technology
Co., Ltd
Add: 301, Hanzhongmen Street, 8F Block A, No.1, Nanjing
International Service Outsourcing Mansion, Nanjing, 210036
China
Contact Person:Ma Jing
Certification engineer
301, Hanzhongmen Street, 8F Block A, No.1, Nanjing
International Service Outsourcing Mansion, Nanjing, 210036
China
Tel: +86-25-83305050,
fax +86-25-58783271
Device Trade Name:JUSHA-M52C Medical Display
Common/Usual Name:Image display system, medical image workstation, image
monitor/display, and others
Classification Name:
Product Code:System, image processing 21CFR 892.2050
90LLZ
Predicate Device(s):JUSHA-M52C;K131390
Device Description:JUSHA-M52C Medical Display is the display system with the
high resolution(2048 x 2560), high luminance(700 cd/m² ),
and 256 simultaneous shades of gray out of a palette of
4096, 8 DICOM look up table inside, the product is consisted
of the following components:
  • 21.3 inch, mono-TFT Liquid Crystal Display
  • Motherboard HDVI-3M V1.0
  • JUSHA-M52C Medical Display software
  • Power Adapter
  • Data Cable. |
    | | The Medical Display is designed, tested, and will be
    manufactured in accordance with both mandatory and
    voluntary standards:
  1. IEC 60601-1Medical equipment medical electrical
    equipment - Part 1: General requirements for
    basic safety and essential performance
    IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ |
    | | EN 60601-1: 2006/AC: 2010 |
    | | 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. |
    | Intended Use: | JUSHA-M52C Medical Display is intended to be used for
    review and analysis by trained medical practitioners in
    displaying and viewing various kinds of medical images
    including digital mammography system. |
    | Technology: | JUSHA-M52C Medical Display is the display system with the
    high resolution monitor (5 megapixels) with electronic
    capabilities for evaluation of high resolution medical images,
    high luminance (700 cd/m²) and 256 simultaneous shades
    of gray out of a palette of 4096, 8 DICOM look up table
    inside |
    | Determination of
    Substantial Equivalence: | Summary of Non-Clinical Tests: |
    | | The Medical Display complies with voluntary standards as
    following:
    1 IEC 60601-1Medical equipment medical electrical
    equipment - Part 1: General requirements for basic
    safety and essential performance |
    | | IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ |
    | | EN 60601-1: 2006/AC: 2010 |
    | | 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-M52C is substantially equivalent to RadiForce G51.
    G51. M52C employs the maximum resolution values same as
    that of RadiForce G51. Comparison table of the principal
    Characteristics of 2 devices is shown in the Attachment 1 . |
    | | Attachment 1 |
    | | The following quality assurance measures were applied to
    the development of the system:
    • Risk Analysis
    • Requirements Reviews |

4

5

| | •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, Medical Display,
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-M52C Medical Display to be as safe, as effective, and
performance is substantially equivalent to the predicate
device(s). |