(85 days)
Not Found
No
The 510(k) summary describes a monochrome LCD monitor for displaying medical images. There is no mention of AI, ML, or any image processing capabilities that would suggest the use of such technologies. The device appears to be a passive display device.
No
The device is a monitor used for displaying medical images for diagnosis, not for treating a disease or condition.
Yes
The device is intended to be used for displaying images for diagnosis of X ray or MRI, which are modalities used for medical diagnosis.
No
The device description explicitly states it is a "20.1" 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 clearly states it's for "displaying for diagnosis of X ray or MRI, etc." This describes a device used to visualize medical images, not a device used to examine specimens (like blood, urine, or tissue) outside the body to obtain diagnostic information.
- Device Description: The description reinforces that it's a "display for medical use."
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in specimens.
- Providing information about a patient's health status based on laboratory tests.
Therefore, the RadiForce G21 monitor is a medical device used for displaying diagnostic images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
20.1" Monochrome LCD Monitor, RadiForce G21 is intended to use in displaying for diagnosis of X-ray or MRI etc.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
20.1" Monochrome LCD Monitor, RadiForce G21 is a display for medical use. This product complies with radiation performance standards.
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
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): 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).
0
K02 4358
510(k) Summary as required by 807.92
MAR 2 5 2003
1. Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Matto-shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
2. Official Correspondent
Hiroaki Hashimoto (Mr.)
3. Date of Submission
December 26, 2002
4. Device Trade name
20.1" Monochrome LCD Monitor, RadiForce G21
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
20.8" Monochrome LCD Monitor, FC-2091 manufactured by EIZO NANAO CORPORATION
8. Description of Device
20.1" Monochrome LCD Monitor, RadiForce G21 is a display for medical use. This product complies with radiation performance standards.
9. Intended Use
20.1" Monochrome LCD Monitor, RadiForce G21 is intended to be used in displaying for diagnosis of X ray or MRI, etc.
10. Compliance standards
Please refer to Appendix 1.
1
Appendix 1: Comparison Table with Predicate Device
.
| Items | FC-2091 | G21 |
|---|---|---|
| 510(k) Number | K022109 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 51 cm (20.1") TFT monochrome LCD panel |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.255 mm x 0.255 mm |
| Available Cabinet Colors | Black | Black |
| Display Colors | 1.531 grayscale tones | 1.531 grayscale tones |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency (H, V) | 92.86 - 96.72Hz, 60Hz | Analog: 31.5 kHz - 130kHz, |
| 50 kHz - 85kHz | ||
| Digital: 31.5 kHz - 75kHz, | ||
| 60 Hz (VGA Text: 70Hz) | ||
| Native Resolutions | 2048 x 1536 (landscape), | |
| 1536 x 2048 (portrait) | 1600 x 1200 (landscape), | |
| 1200 x 1600 (portrait) | ||
| Brightness | 650 cd/m² | 700 cd/m² |
| Contrast Ratio | 600: 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 132MHz | Analog: 240MHz |
| Digital: 162MHz | ||
| Response Time | 50 ms (typical) | 30 ms (typical) |
| Input Signals | DVI Standard 1.0 | RGB Analog, |
| DVI Standard 1.0 | ||
| Input Terminals | DVI-D 24 pin | DVI-D 29 pin, BNC |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream / Rev. 1.1 |
| Serial Ports | D-Sub 9 pin (Remote Out), | |
| Min DIN 6 pin (Remote In) | ||
| Min DIN 8 pin (Photo Sensor) | D-Sub 9 pin (Remote Out), | |
| Min DIN 6 pin (Remote In) | ||
| Mini DIN 8 pin (Photo Sensor) | ||
| Active Display Size (H x V) | 424 mm x 318 mm | |
| (16.7" x 12.5") | 408 mm x 306 mm | |
| (16.1" x 12.0") | ||
| Viewable Image Size | 529 mm (20.8") (diagonal) | 510 mm (20.1") (diagonal) |
| Power Management | DVI-DMPM | VESA DPMS, DVI-DMPM |
| Power Consumption | 70 watts (typical) | 55 watts (typical) |
| Power Save Mode | Less than 15 watts | Less than 8 watts |
| Dimensions (W x H x D) | With Stand: | |
| 368 mm x 520 – 592mm x 209 mm | ||
| (14.5" x 20.5" x 23.3" x 8.2") | ||
| Without Stand: | ||
| 368 mm x 474 mm x 84 mm | ||
| (14.5" x 18.7" x 3.3") | 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") | ||
| NET Weight | With Stand: 9.5 kg (20.9 lbs), | |
| Without Stand: 6.3 kg (13.9 lbs) | With Stand: 10.5 kg (23.1 lbs), | |
| Without Stand: 7.3 kg (16.1lbs) | ||
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1, | |
| UL2601-1, CSA C22.2 No. 601-1, | ||
| FCC-A, Canadian ICES-003-A, | TUV/GM, c-TUV, CE, CB, EN60601-1, | |
| UL2601-1, CSA C22.2 No. 601-1, | ||
| FCC-A, Canadian ICES-003-A, |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EIZO NANAO Corporation % Mr. Akira Wakayama Safety Dept. Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken, 519-05 JAPAN
MAR 2 5 2003
Re: K024358 Trade/Device Name: 20.1" Monochrome LCD Monitor, RadiForce G21 Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 26, 2002 Received: December 30, 2002
Dear Mr. Wakayama:
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
Page 2
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (If known): _Kø 2 43 5 8
Device Name: 20.1" Monochrome LCD Monitor
Indications for Use:
20.1" Monochrome LCD Monitor, RadiForce G21 is intended to use in displaying for diagnosis of X-ray or MRI etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K024358