(18 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a display monitor for viewing medical images, not a device that directly treats or prevents a disease or condition.
Yes
The device is described as "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." by medical practitioners, which directly implies its use in the diagnostic process.
No
The device description explicitly states it is a "Monochrome LCD display," which is a hardware component.
Based on the provided information, the RadiForce GS320 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 GS320's Function: The RadiForce GS320 is a display device used for viewing digital images generated by medical imaging modalities like X-ray and MRI. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis." This is a function related to image interpretation, not in vitro testing.
Therefore, the RadiForce GS320 falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of Xray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
Product codes
LLZ
Device Description
RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
digital images for diagnosis of Xray or MRI, etc.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
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§ 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
AUG - 7 2006
- Company Identification EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan-shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
-
- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
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- Date of Submission June 28, 2006
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- Device Trade name Monochrome LCD Monitor, RadiForce GS320
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- Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
6. Classification Number
Medical displays classified in Class II per 21 CFR 892.2050.
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- Predicate Device
| Manufacturer | : | EIZO NANAO CORPORATION |
|---|---|---|
| Device Name | : | Monochrome LCD Monitor |
| Model Name | : | RadiForce G310 |
| 510(k) No. | : | K060845 |
| Items | GS310 | GS320 |
| 510(k) Number | K060845 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT Monochrome | |
| LCD panel | 54 cm (21.3") TFT Monochrome | |
| LCD panel | ||
| Cabinet Color | Black | It is same as the following. |
| Pixel Pitch | 0.207 x 0.207mm | 0.2115 x 0.2115mm |
| Ratio of Sub-pixel | ||
| Opening Areas | 4: 4: 4 | It is same as the following. |
| Grayscale Tones | 1,024 from a pallet of 8,161 | It is same as the following. |
| Viewing Angles | H: 170°, V: 170° | It is same as the following. |
| Scanning Frequency | ||
| (H, V) | 31-100kHz, 48-71.5Hz | |
| (VGA Text: 69-71Hz) | ||
| Frame synchronous mode: 59-61Hz | It is same as the following. | |
| Native Resolutions | 1536 x 2048 | It is same as the following. |
| Brightness | 700 cd/m² (Typical) | It is same as the following. |
| Contrast Ratio | 900: 1 (typical) | 850: 1 (typical) |
| DOT Clock | 165 MHz | It is same as the following. |
| Response Time | 50 ms (typical) | It is same as the following. |
| Active Display Size | ||
| (H x V) | 318 x 424 mm | 324 x 433 mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 541mm (21.3") (diagonal) |
| Luminance Calibration | Built-in swing calibration sensor | |
| provided. | It is same as the following. | |
| Input Signals | DVI Standard 1.0 | It is same as the following. |
| Input Terminals | DVU-D 24 pin | It is same as the following. |
| USB Ports / Standard | 1 upstream, 2 downstream | 1 upstream, 2 |
| downstream/Standard Rev.2.0 | ||
| Power | AC100-120V, 200-240V, 50/60Hz | It is same as the following. |
| Power Management | DVI-DMPM | It is same as the following. |
| Dimensions (W x H x D) | With Stand: | |
| 368 x 515.5 mm | ||
| – 597.5 x 209 mm | ||
| Without Stand: | ||
| 368 x 486 x 90 mm | With Stand: | |
| 376 x 522.5 mm | ||
| – 604.5x 208.5 mm | ||
| Without Stand: | ||
| 376 x 500 x 92 mm | ||
| Certifications & | ||
| Standards | TUV/GM, CE Medical Device | |
| Directive, CB (EN60601-1), | ||
| cTUVus (UL2601-1, CSA C22.2 No. | ||
| 601-1), VCCI-B, FCC-B, Canadian | ||
| ICES-003-A, CCC | TUV/GM, CE Medical Device | |
| Directive, CB (EN60601-1), | ||
| cTUVus (UL2601-1, CSA C22.2 No. | ||
| 601-1), VCCI-B, FCC-B, Canadian | ||
| ICES-003-A, CCC |
8. Description of Device
RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
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- Intended Use
RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of Xray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
- Intended Use
10. Technological Characteristics
GS320 employs smaller grayscale tones than that of GS310. The only modification is that the panel size became big with 54cm(21.3") from 53cm(20.8"). Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions.
1
・
:
Appendix 1: Comparison Table with Predicate Device
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 lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 7 2006
Mr. Hiraoki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 JAPAN
Re: K062053
Trade/Device Name: Monochrome LCD Monitor, RadiForce GS320 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 3, 2006 Received: July 20, 2006
Dear Mr. Hashimoto:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive, followed by three stars. The text around the circle reads "U.S. Food and Drug Administration".
Protecting and Promoting Public Health
3
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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. Hogdon
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 GS320
Indications For Use:
RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for 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 A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number