(19 days)
RadiForce R31 and R31-C are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. These devices must not be used for digital mammography system.
RadiForce R31 and R31-C are 53cm (20.8") Color LCD displays for medical viewing. Each model produces hi·crisp images for modality applications and 3D image fusion. The model difference between R31 and R31-C are the panel protector provided with R31-C and brightness only.
This 510(k) premarket notification (K052344) is for a medical display device, the EIZO NANAO CORPORATION’s Color LCD Monitor, RadiForce R31 and R31-C. It does not contain information about an AI/ML device or its performance study. Therefore, I cannot accurately answer your request.
Medical displays like the RadiForce R31 are evaluated based on display hardware performance specifications (e.g., luminance, resolution, contrast ratio, uniformity, color accuracy) and their ability to render medical images accurately, not on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity that would be generated from a study involving image interpretation by human readers or an AI algorithm.
The provided documentation does not include:
- Acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy.
- Sample sizes for test sets, data provenance, or ground truth establishment.
- Details about expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set information.
Instead, the documentation focuses on the substantial equivalence of the new device to a predicate device (RadiForce R22) based on technical characteristics and intended use for displaying digital images for diagnosis.
{0}------------------------------------------------
510(k) Summ as required by 807.92
SEP 1 4 2005
- 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
-
- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
-
- Date of Submission August 23, 2005
-
- Device Trade name Color LCD Monitor, RadiForce R31 & R31-C
-
- Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
-
- Classification Number Medical displays classified in Class II per 21 CFR 892.2050.
-
- Predicate Device
EIZO NANAO CORPORATION Manufacturer : : 20.8" Color LCD Monitor Device Name : RadiForce R22 Model Name : K033466 510(k) No.
-
- Description of Device
RadiForce R31 and R31-C are 53cm (20.8") Color LCD displays for medical viewing. Each model produces hi·crisp images for modality applications and 3D image fusion. The model difference between R31 and R31-C are the panel protector provided with R31-C and brightness only.
- Description of Device
-
- Intended Use
RadiForce R31 and R31-C are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. These devices must not be used for digital mammography system.
- Intended Use
-
- Technological Characteristics
R31 and R31-C employs the maximum resolution value same as that of R22. Comparison table of the principal characteristics of these devices in Attachment 1 shows the new and predicate devices are substantially equivalent in the areas of technical characteristics, general function. Regarding to the change in software, refer to Software Information for RadiCX used for optional calibration sensor kit. The device does not come into contact with the patient. It does not control any life sustaining devices either. Any difference between these devices does not affect safety or efficacy.
- Technological Characteristics
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle, there is a stylized image of three wavy lines, which are meant to represent a human figure.
Public Health Service
. SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eizo Nanao Corporation % Mr. Shinich Yamanaka Reviewer Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun, Mie-ken, 519-05 JAPAN
Re: K052344 Trade/Device Name: Color LCD Monitor, RadiForce R31 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 24, 2005 Received: August 29, 2005
Dear Mr. Yamanaka:
:
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.
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.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 leath This letter will anow you to begin mancing of substantial equivalence of your device to a legally premarket notification. The PDA miding of Sabstantial of a
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 If you desire specific advice for your device on but has might of
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "firsonation on your responsibilities under the Act from the 807.97). You may obtain other general mionnation on your reports of its toll-free number (800) Division of Birling of Birling of at its Internet address 056-2041 or (2019/04/2019/industry/support/index.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
{3}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________
Color LCD Monitor, RadiForce R31 ・・ Device Name
Indications for Use:
RadiForce R31 is intended to be used in displaying and viewing digital images for diagnosis of X
artistics and the becally be and changes - Those devices must not be used for RadiForce R31 is intended to be used in usplaying and viewing agains and of any of the used for digital mammography system.
Prescription Use _ X (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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052344
§ 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).