(64 days)
No
The summary describes a medical monitor for displaying images, with no mention of AI or ML capabilities.
No
This device is a monitor used for displaying medical images for diagnosis, not for treating a condition or performing a therapeutic function.
Yes
The device is described as "displaying for diagnosis of X-ray or MRI," indicating its role in presenting images for diagnostic purposes.
No
The device is explicitly described as a "TFT Monochrome LCD Monitor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying for diagnosis of X-ray or MRI, etc." This describes a device that presents medical images for interpretation by a healthcare professional.
- Device Description: The description states it is a "display for medical use."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is a medical display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X ray or MRI and others application for medical.
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X-ray or MRI, etc.
Product codes
90 LLZ
Device Description
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is a display for medical use.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
- 2 2003
510(k) Summary as required by 807.92
- Company Identification
IIYAMA CORPORATION 710-1 Kitaowaribe, Nagano city, Nagano Pref. 381-0014, Japan TEL: +81-26-263-5114 FAX: +81-26-263-5124
- Official Correspondent
Kazuyoshi Tateiwa (Mr.) / Deputy Group Manager Visual-Media Control Division Technical Support Group Technical No. 2 Dept.
3. Date of Submission
June 26, 2003
-
- Device Trade name
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW
- Device Trade name
5. Common Name
Monitor, display, workstation, and others
6. Classification
Medical displays were classified in Class II per 21 CFR 890.2050.
7. Predicate Device
| Manufacturer | : EIZO NANAO CORPORATION | |
|---|---|---|
| Device Name | : 20.1" Monochrome LCD Monitor | |
| Model Name | : RadiForce G21 | |
| 510(k) No. | : K024358 | |
| Items | G21 | MU5111BW |
| 510(k) Number | K024358 | |
| Panel Size and Type | 51 cm (20.1") TFT monochrome LCD panel | 51cm(20.1") TFT monochrome LCD panel |
| Pixel Pitch | 0.255 mm x 0.255 mm | 0.255mm x 0.255mm |
| Available Cabinet Colors | Black | Black |
| Display Colors | 1,531 grayscale tones | Maximum 256-level monochrome |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency (H, V) | Analog: 31.5 kHz – 130kHz, | |
| 50 kHz – 85kHz | ||
| Digital: 31.5 kHz - 75kHz, | ||
| 60 Hz (VGA Text: 70Hz) | fH: 24.0-80.0kHz, | |
| fv : 56-85Hz | ||
| Native Resolution | 1600 x 1200 (landscape), | |
| 1200 x 1600 (portrait) | 1600 x1200 (Landscape) | |
| 1200 x1600 (Portrait) | ||
| Brightness | 700 cd/m² | 700cd/m²(Typical) |
| Contrast Ratio | 1000: 1 (Typical) | 1000: 1 (Typical) |
| DOT Clock | Analog: 240MHz | |
| Digital: 162MHz | Digital: 162MHz | |
| Response Time | 30 ms (typical) | 25ms |
| Input Signals | RGB Analog, | |
| DVI Standard 1.0 | Analog: 0.7Vp-p(Standard), 75Ω Positive | |
| Digital: DVI Standard Rev.1.0 | ||
| Input Terminals | DVI-D 29 pin, | |
| BNC | DVI-I 29pin | |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1upstream, 4downstream, Rev. 2.0/1.0 |
| Serial Ports | D-Sub 9 pin (Remote Out), | |
| Min DIN 6 pin (Remote In) | ||
| Mini DIN 8 pin (Photo Sensor) | Not provided. | |
| Active Display Size (H, V) | 408 mm x 306 mm | |
| (16.1" x 12.0") | 408 mm x 306 mm | |
| (16.1" x 12.0") | ||
| Viewable Image Size | 510 mm (20.1") (diagonal) | 510mm (20.1") (diagonal) |
| Power Management | VESA DPMS | |
| DVI-DMPM | VESA DPMS | |
| Power Consumption | 55 watts (typical) | 70 watts maximum |
| Power Save Mode | Less than 8 watts | Less than 5 watts |
| Dimensions (W x H x D) | With Stand: | |
| 449 mm x 456 – 528 mm x 209 mm | ||
| (17.7" x 18.0" x 20.8" x 8.2") | ||
| Without Stand: | ||
| 449 mm x 347 mm x 86.5 mm | ||
| (17.7" x 13.7" x 3.4") | 466 x 424 – 534 x 241 mm / 18.3×16.7-21×9.5" | |
| Luminance Calibration | Software (Standard) | |
| Photo-sensor (Standard) | ||
| Protection panel (Standard) | No calibration software used. | |
| Auto adjustment function provided. | ||
| Power | 10V-120V/200V-240V, 50/60Hz, | |
| 0.65A-0.4A, 0.35A-0.2A | 100-230VAC, 50/60Hz 0.7-0.35A | |
| NET Weight | With Stand: 10.5 kg (23.1 lbs), | |
| Without Stand: 7.3 kg (16.1lbs) | 10kg / 22lbs | |
| Certification & Standards | TUV/GM, c-TUV, CE, CB, EN60601-1, | |
| UL2601-1, CSA C22.2 No. 601-1, FCC-A, | Under applications for | |
| UL / C-UL, TUV-GS, CB, |
8. Description of Device
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is a display for medical use.
9. Intended Use
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X ray or MRI and others application for medical. This is the same intended use for the previously cleared for RadiForce G21, K024358.
10. Compliance standards
Please refer to Appendix 1.
1
Appendix 1: Comparison Table with Predicate Device
- Comparing to a predicate device, EIZO NANAO RadiForce 21, Iiyama's MU5111BW has only a ● few differences. MU5111BW does not have serial ports, and automatic adjustment function provided. However, the basic structure of both models is the same in terms of LCD display with stand and its functions.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird inside a circle. The bird is composed of three curved lines that suggest wings and a body. The circle surrounding the bird is made up of small, indistinct shapes, possibly letters or symbols. The logo is black and white and appears to be a simple, graphic design.
ood and Drug Administration 0 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
Mr. Kazuyoshi Tateiwa Deputy Group Manager Ilyama Corporation 710-1 Kitaowaribe, Nagano City, Nagano Pref., 381-0014 JAPAN
Re: K032020
Trade/Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system
Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2003 Received: July 10, 2003
Dear Mr. Tateiwa:
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.
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); 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.
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICAITIONS FOR USE STATEMENT
KO3 2020 510(k) Number (If known):
Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW
Indications for Use:
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X-ray or MRI, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
and Ra 510(k) Numb
Prescription Use (Per 21CFR 801.109)
OR
Over The Counter Use_