(30 days)
No
The 510(k) summary describes a medical monitor and does not mention any AI or 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 providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used in displaying for diagnosis in CT, DSA, or MRI," which directly indicates a diagnostic purpose.
No
The device description explicitly states that RadiForce G22 is a "monitor for medical use," which is a hardware component.
Based on the provided information, the RadiForce G22 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.
- RadiForce G22's Function: The RadiForce G22 is a medical monitor used for displaying medical images generated by imaging modalities like CT, DSA, and MRI. It is a display device, not a test that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "displaying for diagnosis in CT, DSA, or MRI, etc." This describes a display function for interpreting images, not a diagnostic test performed on a sample.
Therefore, the RadiForce G22 falls under the category of a medical device used for displaying diagnostic images, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Monochrome LCD Monitor, RadiForce G22 is intended to be used in displaying for diagnosis of in CT, DSA, and MRI, etc. These intended usages are same as that of the predicate model of FC2091, K022109.
RadiForce G22 is intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.
Product codes
90 LLZ
Device Description
G22 provides 2 mega pixel (1200 x 1600) RadiForce G22 is a monitor for medical use. readly of or and 10 bit (1,024 tones) simultaneous grayscale display for accurate diagnosis in CT, DSA, and MRI, etc, except for a digital mammography system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, DSA, 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
JUN 2 4 2004
510(k) Summary as required by 807.92
1. Company Identification
EIZO NANAO CORPORATION E120 NANAO OOILI Ola1110.shi, Ishikawarken, 924.8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
-
- Official Correspondent
Hiroaki Hashimoto (Mr.)
- Official Correspondent
3. Date of Submission
June 8, 2004
-
- Device Trade name
Monochrome LCD Monitor, RadiForce G22
- Device Trade name
5. Common Name
Monitor, display, workstation, and others
-
- Classification
Medical displays were classified in Class II per 21 CFR 890.2050.
- Classification
7. Predicate Device
: EIZO NANAO CORPORATION Manufacturer : 20.8" Monochrome LCD Monitor Device Name : FC-2091 Model Name : K022109 510(k) No.
8. Description of Device
G22 provides 2 mega pixel (1200 x 1600) RadiForce G22 is a monitor for medical use. readly of or and 10 bit (1,024 tones) simultaneous grayscale display for accurate diagnosis in CT, DSA, and MRI, etc, except for a digital mammography system.
-
- Intended Use
Mooochrome LCD Monitor, RadiForce G22 is intended to be used in displaying for diagnosis of in CT, DSA, and MRI, etc. These intended usages are same as that of the predicate model of FC2091, K022109.
- Intended Use
-
- Comparison of technological characteristics between new device and predicate device Please refer to Appendix 1.
-
- Compliance standards Please refer to Appendix 1.
1
| Items | FC-2091 | G22 |
|---|---|---|
| 510(k) Number | K022109 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 19.6" Class Monochrome LCD Monitor |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.294 mm x 0.294 mm |
| Available Cabinet Colors | Black | Black, Gray |
| Display Colors | 1.531 grayscale tones | 1,024 million grayscale tones from a pallet of 3,061 |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency (H, V) | 92.86 - 96.72 Hz, 60 Hz | 75 kHz, 60 Hz |
| Native Resolutions | 2048 mm x 1536 mm (landscape), | |
| 1536 mm x 2048 mm (portrait) | 1200 mm x 1600 mm | |
| Brightness | 650 cd/m² | 800 cd/m² |
| Contrast Ratio | 600 : 1 (typical) | 600 : 1 (typical) |
| DOT Clock | 132MHz | 162 MHz |
| Response Time | 50 ms (typical) | 40 ms (typical) |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVI-D 24 pin | DVI-D 24 pin |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream / Rev. 2.0 |
| Active Display Size (H x V) | 424 mm x 318 mm | 398 mm x 299 mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 498 mm (diagonal) |
| Luminance Calibration | Software (Optional) | |
| Photo-sensor (Optional) | Software (Optional) | |
| Photo-sensor (Optional) | ||
| Power | AC100-120V/200-240V, 50/60Hz | AC100-120V/200-240V, 50/60Hz |
| Power Management | DVI-DMPM | DVI-DMPM |
| Power Consumption | 70 watts (typical) | 70 watts (typical) |
| Power Save Mode | Less than 15 watts | Less than 6 watts |
| Dimensions (W x H x D) | With Stand: | |
| 368 x 520 mm – 592 x 209 mm | ||
| Without Stand: | ||
| 368 mm x 474 mm x 84 mm | With Stand: | |
| 337 x 493 mm – 575 x 208.5 mm | ||
| Without Stand: | ||
| 337 mm x 441 mm x 78.5 mm | ||
| NET Weight | With Stand: 9.5 kg | |
| Without Stand: 6.3 kg | With Stand: 9.1 kg | |
| Without Stand: 5.9 kg | ||
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1, | |
| UL2601-1, CSA C22.2 No. 601-1, | ||
| FCC-A, Canadian ICES-003-A, | ||
| VCCI-A, FDA 510(k) | TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus | |
| (UL2601-1, CSA C22.2 No. 601-1), | ||
| FCC-B, Canadian ICES-003-A, | ||
| VCCI-A, EIZO ECO Products 2002 |
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 stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2004
Mr. Hiroaki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Matto, Ishikawa 924-8566 JAPAN
Re: K041597 Trade/Device Name: Monochrome LCD Monitor, RadiForce G22 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 8, 2004 Received: June 14, 2004
Dear Mr. Hashimoto:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Scenon > Po(x) promation is substantially equivalent (for the indications relerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manage of the Medical Device American be of Days commerce phor to May 20, 1976, the closener with the provisions of the Federal Food, DNA devices that have been resulted in assoredance approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The You may, therefore, market the device, easy of every of ennual registration, listing of general controls provisions of the rice 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 If your device is classified (soo aoore) ins. Existing major regulations affecting your device can may be subject to such additional och. One - Little 21, Parts 800 to 898. In addition, FDA may oc found in the OOGS acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a cases in the ther requirements of the Act that FDA hade a decemmation that your cover correst by other Federal agencies. You must comply
of any Federal statutes and regulations administered by other Federal and CEP P or any Federal statutes and regalations administration and listing (21 CFR Part with an the Act s requirements, meracting practice requirements as set forth in the 807), labeling (21 CFR Part 820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if application (2006) 1950 quality systems (QB) regardice (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) I ms letter will anow you to ocgin manioung your device of your device of your device to a legally premarket notincation: "The PDF intellig sification 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 If you desire specific advice to: your General 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 Additionally, 10. questions on and please note the regulation entitled, "Misbranding Other of Comphanoour (2017 07 1 33 (21 CFR Part 807.97) you may obtain. Other general by receice to premarred notified.out (er the Act may be obtained from the Division of Small mormation on your responsionner Assistance at its toll-free number (800) 638-2041 or 11andraocarers, 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
Indications for Use
510(k) Number (if known): Not-known
Device Name: Monochrome LCD Monitor, RadiForce G22
Indications For Use:
finaletterns 1 0 - 2 - 11:11
RadiForce G22 is intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.
Prescription Use
(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)
David h. Lyman