RadiForce RX210 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.

Device Description

RadiForce RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 displays high-definition medical imaging.

AI/ML Overview

This is a 510(k) premarket notification for a medical display, not a medical device that performs diagnostic analysis. Therefore, the traditional acceptance criteria and study design for evaluating diagnostic performance (like those involving sensitivity, specificity, expert readers, etc.) are not applicable here.

The document describes the RadiForce RX210 Color LCD Monitor and establishes its substantial equivalence to a predicate device (RadiForce R22, K033466) based on technological characteristics and intended use.

Here's the information derived from the provided text, adapted to the context of a medical display’s regulatory review:

1. Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence)

For medical displays, acceptance criteria typically revolve around demonstrating that the new device performs at least as well as, or is substantially equivalent to, an already legally marketed predicate device, especially in key performance parameters relevant to image display for diagnosis.

Acceptance Criteria Category	Specific Criteria (Implicitly from Predicate)	RadiForce RX210 Reported Performance
Image Resolution	Same as predicate (1600 x 1200)	1600 x 1200 (same as predicate)
Panel Size & Type	54 cm (21.3") TFT color LCD panel	54 cm (21.3") TFT color LCD panel (same as predicate)
Pixel Pitch	0.270 x 0.270 mm	0.270 x 0.270 mm (same as predicate)
Display Colors	16,777,216 colors	16,777,216 colors (same as predicate)
Viewing Angles	H: 170°, V: 170°	H: 170°, V: 170° (same as predicate)
Brightness	250 cd/m² (predicate)	600 cd/m² (Typical) (improved)
Contrast Ratio	400:1 (typical) (predicate)	600:1 (typical) (improved)
Response Time	50 ms (typical) (predicate)	25 ms (typical) (improved)
Luminance Calibration	Software (Optional), Photo-sensor (Optional), Protection Panel (Optional)	Software (Optional), Photo-sensor (Optional), Protection Panel (Optional), Digital Uniformity Equalizer (DUE) (improved/added feature)
Intended Use	Displaying and viewing digital images for diagnosis of X-ray or MRI etc. by trained medical practitioners (Not for digital mammography systems)	Same as predicate

Study Proving Acceptance Criteria (Substantial Equivalence Justification):

The "study" in this context is the comparison presented in the 510(k) submission, primarily in the form of a comparison table (Appendix 1 / {1}) and a narrative describing the technological characteristics and intended use. It demonstrates that the new device, RadiForce RX210, is substantially equivalent to the predicate device, RadiForce R22 (K033466).

The key argument is that the RX210 maintains the core functional aspects (like resolution, panel type, pixel pitch) of the predicate device while introducing improvements (higher brightness, contrast, faster response time, and the addition of Digital Uniformity Equalizer (DUE) for luminance non-uniformity compensation). The intended use is identical, and the software for calibration remains unchanged.

Regarding the other requested information (which are generally not applicable to this type of device submission):

2. Sample sized used for the test set and the data provenance: Not applicable. This submission is for a display monitor, not an algorithm or diagnostic test evaluated on a dataset of patient images. The "test" is a comparison of technical specifications against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth in the sense of diagnostic accuracy for a display monitor itself. The "ground truth" here is the established performance and safety of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware device for display, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, traditional ground truth for diagnostic accuracy is not relevant here. The ground truth for this submission is the regulatory acceptance and safety/effectiveness of the predicate device, against which the new device's technical specifications are compared.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K063120

NOV - 9 2006

. ...

510(k) Summary as required by 807.92

1. 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

1. Official Correspondent
  Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
1. Date of Submission October 2nd, 2006
1. Device Trade name Color LCD Monitor, RadiForce RX210
1. Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
1. Classification Number

Medical displays classified in Class II ver 21 CFR 892,2050.

1. Predicate Device
  Manufacturer : EIZO NANAO CORPORATION Device Name .. Color LCD Monitor Model Name : RadiForce R22 510(k) No. : K033466

8. Description of Device

RadiForce RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 displays high-definition medical imaging.

9. Intended Use

10. Technological Characteristics

RadiForce RX210 is substantially equivalent to R22. RX210 employs the maximum resolution values same as that of R22. Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non uniformity, And the brightness improved.

Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.

{1}------------------------------------------------

Items	R22	RX210
510(k) Number	K033466	Not known
Panel Size and Type	54 cm (21.3") TFT color LCD panel	It is same as the following.
Cabinet Color	Black	It is same as the following.
Pixel Pitch	0.270 x 0.270mm	It is same as the following.
Display colors	1.6777,216 colors	It is same as the following.
Viewing Angles	H: 170°, V: 170°	It is same as the following.
Scanning Frequency(H, V)	Analog:31-94kHz, 49-86HzDigital:31-76, 59-61Hz(VGA Text:69-71Hz)	Analog:24-100kHz, 49-86HzDigital:31-100kHz, 59-61Hz(VGA Text:69-71Hz)
Native Resolutions	1600 x 1200 (landscape)	It is same as the following.
Brightness	250 cd/m²	600 cd/m² (Typical)
Contrast Ratio	400: 1 (typical)	600: 1 (typical)
DOT Clock	Analog:202.5MHzDigital:162MHz	Analog:202.5MHzDigital: 162MHz
Response Time	50 ms (typical)	25 ms (typical)
Active Display Size(H x V)	432mm x324mm	It is same as the following.
Viewable Image Size	540 mm (21.3") (diagonal)	It is same as the following.
Luminance Calibration	Software (Optional)Photo-sensor (Optional)Protection Panel (Optional)	Software (Optional)Photo-sensor (Optional)Protection Panel (Optional)Digital Uniformity Equalizer
Input Signals	RGB AnalogueDVI Standard 1.0	It is same as the following.
Input Terminals	DVI-D 29 pinD-sub mini 15 pin	It is same as the following.
USB Ports / Standard	1 upstream / Rev.1.1	1 upstream, 2downstream/Standard Rev.2.0
Power	AC100-120V, 200-240V, 50/60Hz	It is same as the following.
Power Management	DVI-DMPMVESA DPMS	It is same as the following.
Dimensions (W x H x D)	With Stand:472 x 459 mm- 541 x 208.5 mmWithout Stand:472 x 373 x 69 mm	With Stand:376 x 522.5 mm- 604.5x 208.5 mmWithout Stand:376 x 500 x 92 mm
Certifications &Standards	TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B, CanadianICES-003-B, CCC	TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL60601-1, CSA C22.2No. 601-1), VCCI-B, FCC-B,Canadian ICES-003-B, CCC

Appendix 1: Comparison Table with Predicate Device

Since the software used in R22 is not changed, refer to the 510(k) Summary of 5033466 for the information of calibration software.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of three human faces in profile, stacked on top of each other. The faces are drawn with thick, black lines, giving them a bold and graphic appearance. To the left of the faces, there is text arranged in a curved, vertical format, although the specific words are not clear due to the image quality.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Hiroaki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 JAPAN

NOV - 9 2006

Re: K063120

Trade/Device Name: Color LCD Monitor, Radiforce RX210 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 2, 2006 Received: October 12, 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 is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three dots at the bottom of the circle.

ing Public .

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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 1000-0500

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, permitts 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 Assommer Assommer 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

Page 2 -

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Indications for Use

510(k) Number (if known): Not known KOG 3120

Color LCD Monitor, RadiForce RX210 Device Name :

Indications For Use:

RadiForce RX210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. TThe 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)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive. Abdomin and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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).