(23 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No
This device is a display monitor used for viewing medical images, not for direct therapeutic intervention. It aids in diagnosis but does not provide therapy.
No
The device is a medical display, used for viewing and displaying images. It does not perform any diagnostic function itself. The diagnostic function is performed by trained medical practitioners who use the images displayed by the device.
No
The device description explicitly states it is a "Monochrome LCD display," which is a hardware component.
Based on the provided information, the RadiForce GX320 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 GX320's Function: The RadiForce GX320 is a display device used for viewing digital medical images (X-ray, MRI, etc.). It does not perform any tests on biological samples. Its role is to present images generated by other diagnostic devices.
Therefore, the RadiForce GX320 falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RadiForce GX320 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.
Product codes
LLZ
Device Description
RadiForce GX320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GX320 displays high-definition medical imaging.
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
trained medical practitioners
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
K070/22
510(k) Summary as required by 807.92
1. Company Identification
FEB 8 20
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
2. Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
3. Date of Submission
January 9, 2007
4. Device Trade name
Monochrome LCD Monitor, RadiForce GX320
5. Common/Usual Name
lmage display system, medical image workstation, image monitor/display, and others
6. Classification Number
Medical displays classified in Class II per 21 CFR 892.2050.
7. Predicate Device
: EIZO NANAO CORPORATION Manufacturer Monochrome LCD Monitor Device Name · · : RadiForce GS320 Model Name 510(k) No. 20 : K062053
8. Description of Device
RadiForce GX320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GX320 displays high-definition medical imaging.
9. Intended Use
RadiForce GX320 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.
10. Technological Characteristics
RadiForce GX320 is substantially equivalent to GS320 (E062053). Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. The built-in swing calibration sensor and the Protection Panel are equipped with GX320 as standard feature. 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. Regarding to upgrade in software, refer to Software Information for RadiCX ver.2.5 used for built-in swing calibration sensor. The device does not come into contact with the patient. It does not control any life-sustaining device either. Any difference between both devices not affects safety or efficacy.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
8 2007 FEB
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation Engineering Management Section 153 Shimokashiwano-cho Hakusan, Ishikawa-ken 924-8566 JAPAN
Re: K070122
Trade/Device Name: Monochrome LCD Monitor, RadiForce GX320 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 9, 2007 Received: January 16, 2007
Dear Mr. Hishimoto:
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 coomerce 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/1/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "FDA" in the center, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo appears to be a commemorative seal for the centennial of the Food and Drug Administration (FDA).
Protecting and Promoting Public Health
2
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/cdrl/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
3
Indications for Use
510(k) Number (if known): Net-known C: 7 Ol ≥ 2
Device Name : Monochrome LCD Monitor, RadiForce GX320
Indications For Use:
RadiForce GX320 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)
Daniel B. Sypm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070122
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