(88 days)
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No
The document describes a medical monitor, which is a display device. There is no mention of AI/ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is a monitor used for displaying medical images for diagnosis, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to be used in displaying for diagnosis of X-ray or MRI," which directly indicates its role in diagnostic processes.
No
The device description explicitly states it is a "20.1 inches monochrome monitor for medical use," 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." This describes a device used to visualize medical images, which are generated from within the body (in vivo).
- 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 Description: The description confirms it's a "monochrome monitor for medical use," further supporting its role in displaying images rather than performing tests on biological samples.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, test procedures, or any other elements typically associated with IVD devices.
Therefore, the RadiForce G20 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 G20 is intended to be used in displaying for diagnosis of X-ray or MRI.
Product codes
90 LLZ
Device Description
RadiForce G20 is 20.1 inches monochrome monitor for medical use. This model has specification of resolution in 1600 x 1200 or 1200 x 1600 and is certified for IEC60601-1 of medical safety standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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Description of the test set, sample size, data source, and annotation protocol
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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
510(k) Summary as required by 807.92
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
January 27, 2003
4. Device Trade name
20.1" Monochrome LCD Monitor, RadiForce G20
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
RadiForce G20 is 20.1 inches monochrome monitor for medical use. This model has specification of resolution in 1600 x 1200 or 1200 x 1600 and is certified for IEC60601-1 of medical safety standard.
9. Intended Use
20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.
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- Comparison of technological characteristics between new device and predicate device Please refer to Attachment 1.
-
- Compliance standards Plaaco rafar to Attachmont 1
1
Appendix 1: Comparison table with predicate device
| Items | FC-2091 | G20 |
|---|---|---|
| 510(k) Number | K022109 | |
| 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 | 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 | Digital: 162MHz |
| Response Time | 50 ms (typical) | 30 ms (typical) |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVI-D 24 pin | DVI-D 29 pin |
| 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), | |
| Mini 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 | 10V-120V/200V-240V, 50/60Hz, 0.7A-0.4A, 0.4-0.2A | 10V-120V/200V-240V, 50/60Hz, 0.65A-0.4A, 0.35A-0.2A |
| Power Management | DVI-DMPM | 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 20.5" x 23.3" x 8.2") | 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, |
| VCCI-A, FDA 510(k) | TUV/S, VCCI-A |
2
Image /page/2/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 a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2003
Eizo Nanao Corportaion % Mr. Akira Wakayama Safety Department Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-05, JAPAN
Re: K030347
Trade/Device Name: 20.1" Monochrome LCD Monitor, RadiForce G20 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: January 29, 2003 Received: February 3, 2003
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 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
Enclosure
4
January 27, 2003
STATEMENT OF INDICATIONS FOR USE
KU3034 510(k) Number (If known):
Device Name: 20.1" Monochrome LCD Monitor
Indications for Use:
20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.
(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)
510(k) Number