K Number
K141690
Device Name
JUSHA-M33C LCD MONITOR
Date Cleared
2014-08-01

(39 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-M33C 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.
Device Description
JUSHA-M33C LCD Monitor is the display system with the high resolution (2048*1536), 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-M33C 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- 45T motherboard/FR-4/REV:0.9 - JUSHA-M33C 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: 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.
More Information

EIZO GX340;K113784

Not Found

No
The description focuses on display characteristics and standard compliance, with no mention of AI/ML algorithms for image analysis or processing. The "ambient brightness adapting and presence induction system" appears to be a simple sensor-based automation, not indicative of AI/ML.

No
The Intended Use / Indications for Use section states that the device is "intended to be used in displaying and viewing digital images for diagnosis," which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a disease or condition.

Yes

Explanation: The device is intended for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." which directly supports diagnostic activities by medical practitioners.

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 "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This describes a device used to present medical images to a practitioner for interpretation, not a device that performs tests on biological samples to diagnose a condition.
  • Device Description: The description details a high-resolution LCD monitor with features for displaying medical images. It does not mention any components or processes related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analysis of biological samples (blood, urine, tissue, etc.)
    • Reagents or assays
    • Measurement of biomarkers or analytes
    • Diagnostic results derived from sample analysis

The device is clearly a medical imaging display intended for use by trained medical practitioners to view images generated by other diagnostic modalities (X-ray, MRI). This falls under the category of medical devices, but not specifically In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

JUSHA-M33C 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.

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

PGY

Device Description

JUSHA-M33C LCD Monitor is the display system with the high resolution (2048*1536), 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-M33C 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- 45T motherboard/FR-4/REV:0.9
  • JUSHA-M33C 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:
  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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray or MRI, etc.

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-M33C is substantially equivalent to EIZO GX340. JUSHA-M33C employs the maximum resolution values same as that of EIZO GX340. 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 GX340;K113784

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 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 caduceus is a common symbol associated with 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: K141690

Trade/Device Name: Jusha-M33C 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,

Smh.7)

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)

K141690

Device Name

JUSHA-M33C LCD Monitor

Indications for Use (Describe)

JUSHA-M33C 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.

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)

Image /page/2/Picture/15 description: The image shows a signature in black ink. The signature is illegible, but it appears to be written in cursive. The background of the image is white. The signature is the main focus of the image. There is a faint watermark in the background.

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."

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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: 8A, Block 1. Nanjing International Service Outsourcing
Mansion, No. 301, Hanzhongmen street, Nanjing, 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-M33C LCD Monitor
Common/Usual Name:3MP Monochrome LCD Monitor
Classification Name: Product
Code:Display, Diagnostic Radiology 21CFR 892.2050
PGY
Predicate Device(s):EIZO GX340;K113784
Device Description:JUSHA-M33C LCD Monitor is the display system with the high
resolution (2048*1536), 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-M33C 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- 45T motherboard/FR-4/REV:0.9
  • JUSHA-M33C 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:
  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. |

4

| Intended Use: | JUSHA-M33C 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. | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Technology: | JUSHA-M33C 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 (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. In
particular, JUSHA-M33C 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-M33C 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-M33C is substantially equivalent to EIZO GX340. JUSHA-
    M33C employs the maximum resolution values same as that of EIZO
    GX340. 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-
    M33C LCD Monitor to be as safe, as effective, and performance is
    substantially equivalent to the predicate device(s). | | |

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510(k) Premarket Notification Submission

Attachment 1

AttributesPredicate DeviceProposed Device
ProductEIZO GX340JUSHA-M33C LCD Monitor
510(k) NumberK113784K141690
Screen technology21.3" Monochrome TFT LCD
Panel21.3inches, Mono-TFT LCD Panel
Viewing angle (H, V)Horizontal 176°,Vertical 176°Horizontal 176°,Vertical 176°
Resolution2048 x 1536/1536x 20482048 x1536/1536x 2048
Display area324.8 (H) x 433.1 (V) mm325.00 (H) x 433.00 (V) mm
Contrast Ratio1400:11400:1
Scanning frequency (H; V)31127 kHz;2961.5 Hz96.7kHz;60Hz
Recommended
Luminance500cd/m²500cd/m²
Pixel Pitch0.2115x0.2115 mm0.2115x0.2115 mm
BacklightLEDLED
DICOM LUT10-bit (Display Port) : 1024
8-bit: 2564096
Luminance calibrationBuilt in calibration sensor providedBuilt in calibration sensor provided
Input signalsDVI standard 1.0,
DisplayPort 1.1aDVI standard 1.0,
DisplayPort 1.1a
Input terminationalDVI-D (dual link) x 1, DisplayPort x 1DVI-D (dual link) x 1, DisplayPort x 1

6

510(k) Premarket Notification Submission
Display controllerOff the shelfOff the shelf
Power RequirementAC 100240V 5060HzAC 100240V 5060Hz
Power
Consumption/Save
Mode36W/less than1.6W45W/less than 3W
Power ManagementDVI DMPM
DisplayPort 1.1aDVI DMPM
DisplayPort 1.1a
USB Ports/standard1 upstream (endpoint),
2 downstream/ Rev. 2.01 upstream (endpoint),
2 downstream/ Rev. 2.0
Dimensions w/o stand
(W x H x D)Without stand:
376mmx505mmx98mm
With stand:
376mmx599mmx245.5 mmWithout stand:
382mm x490mm x75mm With stand:
382mm x533mm x238mm
Applicable standard1 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 tests1 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.