(21 days)
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a display monitor used for viewing diagnostic images; it does not directly provide therapy.
No
This device is a display monitor used for viewing images for diagnosis, not a diagnostic device itself. It does not perform the diagnosis but rather presents the images to a trained medical practitioner who then makes the 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 RX320 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RadiForce RX320's function: The RadiForce RX320 is a display device. Its purpose is to display digital images generated by other medical imaging modalities (X-ray, MRI, etc.). It does not analyze or process biological specimens.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis". This aligns with a medical image display, not an IVD.
Therefore, the RadiForce RX320 falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.
Product codes
LLZ
Device Description
RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 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
16090045
510(k) Summarv 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
JAN 2 8 2009
-
- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Product Safety
-
Date of Submission January 6, 2009
-
Device Trade name Color LCD Monitor, RadiForce RX320
5. 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.
7. Predicate Device
Manufacturer : EIZO NANAO CORPORATION Device Name : Color LCD Monitor Model Name : RadiForce R31 and R31-C 510(k) No. : K052344
8. Description of Device
RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.
9. Intended Use
RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.
10. Technological Characteristics
RadiForce RX320 is substantially equivalent to R31 and R31-C (K052344). Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. RX320 improved the brightness and contrast of the LCD module, and modified the calibration software. The brightness improved in 900 cd/m2 from 400 cd/m2. The contrast improved by it.
Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
1
Appendix 1: Comparison Table with Predicate Device
| Items | R31 | R31-C | RX320 |
|---|---|---|---|
| 510(k) Number | K052344 | Not Provided | |
| Panel Protector | Not provided | Provided | Optional |
| Panel Size and | |||
| Type | 53 cm (20.8") TFT Color LCD panel | 54cm (21.2") TFT Color | |
| LCD panel | |||
| Pixel Pitch | 0.207 x 0.207mm | 0.21075 x 0.21075 mm | |
| Cabinet Color | Black | Same as R31 and R31-C | |
| Display Colors | 10-bit: 1.06 billion (maximum) | ||
| 8-bit: 16.77 million from a palette of 1.06 | |||
| billion | Same as R31 and R31-C | ||
| Viewing Angles | H: 170°, V: 170° | Same as R31 and R31-C | |
| Scanning | |||
| Frequency | |||
| (H, V) | 31-127kHz, 59-61Hz | ||
| (VGA Text: 69-71Hz, | |||
| QXGA: 36-61Hz) | |||
| Frame synchronous mode: 59-61Hz | 31-127kHz, 29-61Hz | ||
| (VGA Text: 69-71Hz) | |||
| Frame synchronous mode: | |||
| 59-61Hz | |||
| Native Resolutions | 2048 x 1536 (portrait) | ||
| /1536 x 2048 (landscape) | Same as R31 and R31-C | ||
| Brightness | 400 cd/m² | 900 cd/m² | |
| Contrast Ratio | 400 : 1 (typical) | 1000 : 1 (typical) | |
| DOT Clock | 215 MHz | Same as R31 and R31-C | |
| Response Time | 50 ms (typical) | 20 ms (typical) | |
| Active Display Size | |||
| (H x V) | 318 x 424 mm | 323.7 x 431.6 mm | |
| Viewable Image | |||
| Size | Diagonal: 529 mm | Diagonal: 540 mm | |
| Luminance | |||
| Calibration | Software (Optional) | ||
| Photo-sensor (Optional) | Software (Optional) | ||
| Photo-sensor (Optional) | |||
| Digital Uniformity | |||
| Equalizer | |||
| Input Signals | DVI Standard 1.0 | Same as R31 and R31-C | |
| Input Terminals | DVI-D 24 pin | Same as R31 and R31-C | |
| USB Ports / | |||
| Standard | 1 upstream, 2 downstream | Same as R31 and R31-C | |
| Power | AC100-120V, 200-240V, 50/60Hz | Same as R31 and R31-C | |
| Power | |||
| Management | DVI-DMPM | Same as R31 and R31-C | |
| Dimensions | |||
| (W x H x D) | With Stand: | ||
| 368 x 515.5 mm |
- 597.5 x 209 mm
Without Stand:
368 x 486 x 88.5 mm | | Same as R31 and R31-C |
| 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 | | CE (Medical Device
Directive), TUV/GM
(EN60601-1), cTUVus (UL
60601-1, CSA C22.2 No.
601-1), CB(IEC60601-1),
VCCI-B, FCC-B, Canadian
ICES-003-B, c-Tick, RoHs |
*The software used in RX320 is modified, refer to the "12. Information of Software used in RX320".
i : :
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hiroaki Hashimoto Manager of Product Safety EIZO NANAO CORPORATION 153 Shimokashiwano-cho Hakusan, Ishikawa-ken 924-8566 JAPAN
JAN 2 8 2009
Re: K090045
Trade/Device Name: Color LCD Monitor, (RadiForce RX320) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 6, 2009 Received: January 7, 2009
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 (PMA), 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.
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 80); 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 os 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) 276-011 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-011 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-012 |
| Other | (240) 276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppor/index.html.
Sincerely yours.
Janine M. Morris
Acting 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:
Color LCD Monitor, RadiForce RX320 Device Name :
Indications for Use:
RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.
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)
Tom M. Whay
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
5-1