(56 days)
Not Found
No
The device description and intended use clearly state that the device is a monochrome LCD monitor for displaying medical images. There is no mention of any AI or ML capabilities, image analysis, or decision support features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a monitor used to display medical images; it does not directly treat or diagnose a medical condition.
No
The device is described as a monitor used to display images, not to perform analysis or diagnosis itself. It is a display component for medical image applications.
No
The device description clearly states it is a Monochrome LCD Monitor, which is a hardware device used to display images. It also mentions hardware components like USB functions, an optional photo sensor, and a power supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that these are "Monochrome LCD Monitors" used to "display images such as Xray, MRI images." They are output devices for medical imaging systems.
- Intended Use: The intended use is to "be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system." This reinforces their role in displaying images, not performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. Not for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Monochrome LCD Monitors(TX-5M, TX-3M, TX-2M) are used to display images such as Xray, MRI images. These models have resolutions of: 2560x2048, 2048x1536, 1600x1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by SEQUEL IMAGING INC. These models are cortified to the EN60601-1 medical safety standard. The monitors use universal Power Supply compatible with AC100V~240V, 50/60Hz. The graphics card needed for the personal computer is the Real Vision & Matrox Scries. The monitors may be deployed in the portrait or the landscape position.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Xray, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing was performed according to internal company procedures and the monitors were safety certificd to International Standard.
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.
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).
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Exhibit 2 NOV - 2 2007 510K Summary: K072532 DOOYANG SYSTEMS INC. SK Techno Bldg. 7th Floor 16-4, Sungsoo 1-Ga, 2-Dong, Sungdong-Ku, Seoul, 133-710 Korea TEL : 82-2-489-2612 FAX : 82-2-467-4915 Contact: Yun-Hwoi, Ku /Managing Director Date : October 30, 2007
1. Identification of Device :
Proprietary-Trade Name: "Truepix LCD Medical Display Monitor" (Models : TX-5M, TX-3M, TX-2M)
Classification Name: System, Image Processing, Radiological, Product Code: LLZ Common/Usual Name: Radiological Image Processing System, LCD Monitor
2. Equivalent Legally Marketed Devices:
Lumimed MM20, MM30 and MM50 Monitors, K052120
3. Indication for Use (Intended Use) :
Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. Not for use in mammography.
4. Description of the Device
Monochrome LCD Monitors(TX-5M, TX-3M, TX-2M) are used to display images such as Xray, MRI images. These models have resolutions of: 2560x2048, 2048x1536, 1600x1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by SEQUEL IMAGING INC. These models are cortified to the EN60601-1 medical safety standard. The monitors use universal Power Supply compatible with AC100V~240V, 50/60Hz. The graphics card needed for the personal computer is the Real Vision & Matrox Scries. The monitors may be deployed in the portrait or the landscape position.
1
KC72532
Page 2 of 2
:
| Items | Lumimed MM20, MM30
and MM50 Monitors, | New | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|--------------------------------------------------|
| | | Truepix TX-2M | Truepix TX-3M | Truepix IX-5M |
| 510(k) Numbers | K052120 | New | | |
| Manufactures | Heeyoung Cl. | Dooynag Systems Inc. | | |
| Panel Size and Type | 21.3" /20.1" TFT
monochrome LCD display | 21.3" TFT
monochrome CD
display | 21.3" TFT
monochrome LCD
display | 20.1" IFT
monochrome LCD
display |
| Pixel Pitch | 0.270mm x 0.270mm
0.2115mm x 0.2115mm
0.156mm x 0.156mm | 0.270mm x 0.270mm | 0.2115mm x
0.2115mm | 0.156mm x 0.156mm |
| Available Cabinet
Colors | Black | Black | Black | Black |
| Native Resolutions | 1200x1600(portrait)
1600x1200(landscape)
1536x2048 (portrait)
2048x1536(landscape) or
2048x2560 (portrait)
2560x2048(landscape) | 1200x1600 (portrait)
1600x1200 (landscape) | 1536x2048 (portrait)
2048x1536 (landscape) | 2048x2560 (portrait)
2560x2048
(landscape) |
| Brightness | 1000cd/m2 900cd/m2
850cd/m2 | 1000cd/m2 | 800cd/m2 | 850cd/m2 |
| Contrast Ratio | 700:1 700:1 600:1 | 700:1 | 700:1 | 600:1 |
| Dot Clock | 125MHz 130MHz 162MHz | 129MHz | 130MHz | 166.52MHz |
| Network Interface | USB
(1 Up, 2 Downstream) | USB
(1 Up, 4 Downstream) | USB
(1 Up, 4 Downstream) | USB
(1 Up, 4 Downstream) |
| Active Display Size
(HxV) | 432(H) x 324(V)
432(H) x 324(V)
399(H) x 319(V) | 433.152x324.864mm | 433.152x324.864mm | 399.36x319.49mm |
| Dimension (WxHxD) | 472 x 495 x92
472 x 495 x92
438 x 458 x 98 | 505 w x 505 h x 81 d | 505 w x 505 h x 81 d | 445 w x 376 h x 90 d |
| Luminance Calibration | Software (Optional)
Photo-sensor(Optional) | Software (Optional)
Photo-sensor(Optional) | Software (Optional)
Photo-sensor(Optional) | Software (Optional)
Photo-sensor(Optional) |
| Power | AC 100240Volts/60Hz240Volts/60Hz
DC 12V,6,67A | AC 100
DC 12V,6,67A | AC 100240Volts/60Hz240Volts/60Hz
DC 12V,6,67A | AC
100
DC 12V,6,67A |
5. Safety and Effectiveness, comparison to predicate device
6. Testing Information and Conclusion
In all matcrial respects, the Truepix LCD Medical Display Monitors are substantially equivalent to the predicate device. Testing was performed according to internal company procedures and the monitors were safety certificd to International Standard.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES'
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2007
Doovang Systems, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K072532
Trade/Device Name: Truepix LCD Medical Display Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 4, 2007 Received: September 17, 2007
Dear Mr. Kamm:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Page 2
Enclosure
4
Indications for Use
510(k) Number (if known): _ K072532___________________________________________________________________________________________________________________________________________
Device Name: "Truepix LCD Medical Display Monitor"
Indications For Use: Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. These monitors are not intended for use in mammography.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tomu m why
(Division Sign-Off)
Page 1 of 1
(Division Sign-Οπ)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072532