(28 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a medical display used for viewing images for diagnosis, not for actively treating a condition or performing therapy.
Yes
The device is described as "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners," which directly indicates its role in diagnosis.
No
The device description explicitly states it is a "Color LCD display," which is a hardware component.
Based on the provided information, the RadiForce RX210 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The RadiForce RX210 is a display device used for viewing digital images from medical imaging modalities like X-ray and MRI. It does not interact with or analyze biological specimens.
The intended use clearly states it's for "displaying and viewing digital images for diagnosis," which aligns with the function of a medical display, not an IVD.
N/A
Intended Use / 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. The device is not specified for digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
RadiForce RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- Official Correspondent
-
- Date of Submission October 2nd, 2006
-
- Device Trade name Color LCD Monitor, RadiForce RX210
-
- Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
-
- Classification Number
Medical displays classified in Class II ver 21 CFR 892,2050.
-
- Predicate Device
Manufacturer : EIZO NANAO CORPORATION Device Name .. Color LCD Monitor Model Name : RadiForce R22 510(k) No. : K033466
- Predicate Device
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
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.
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, 49-86Hz | |
| Digital:31-76, 59-61Hz | ||
| (VGA Text:69-71Hz) | Analog:24-100kHz, 49-86Hz | |
| Digital: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:202.5MHz | |
| Digital:162MHz | Analog:202.5MHz | |
| Digital: 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 Analogue | |
| DVI Standard 1.0 | It is same as the following. | |
| Input Terminals | DVI-D 29 pin | |
| D-sub mini 15 pin | It is same as the following. | |
| USB Ports / Standard | 1 upstream / Rev.1.1 | 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 | |
| VESA DPMS | It is same as the following. | |
| Dimensions (W x H x D) | With Stand: | |
| 472 x 459 mm- 541 x 208.5 mm | ||
| Without Stand: | ||
| 472 x 373 x 69 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-B, CCC | TUV/GM, CE Medical Device | |
| Directive, CB (EN60601-1), | ||
| cTUVus (UL60601-1, CSA C22.2 | ||
| No. 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.
2
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 .
3
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 -
4
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