2MP COLOR LCD MONITOR, RADIFORCE MX215

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a square made up of smaller black and white squares on the left, and the word "EIZO" in bold black letters on the right. There is a registered trademark symbol next to the "O" in "EIZO". KB31090 Page 1 of 5 # JUL 0 3 2013 EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Name Department Hiroaki Hashimoto Medical System Standards Telephone Fax E-Mail +81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com # 510(k) Summary (in accordance with 21 CFR 807.92) # 1. Company EIZO Corporation 153 Shimokashiwano, Hakusan lshikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484 2. Contact Person Hiroaki Hashimoto # 3. Date of Summary April 15th, 2013 # 4. Device Information - Trade Name/Model: RadiForce MX215 . - Common Name: 2MP Color LCD Monitor . - . Classification Name: System, Image Processing, Radiological - Regulation Number: 21 CFR 892.2050, Product Code LLZ . # 5. Predicate Device - 2MP Color LCD Monitor, RadiForce RS210 (K092613) . {1}------------------------------------------------ # 6. Device Description RadiForce MX215 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1.200 x 1.600 pixels (2MP). Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX215 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset. RadiCS LE. are included in this 510(k) submission as an accessory to the RadiForce MX215. #### 7. Intended Use This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis. #### 8. Comparison of Technological Characteristics The comparison table below enumerates information derived from the product brochures of the each device and different technological characteristics are discussed: {2}------------------------------------------------ | Attributes | Eizo RadiForce<br>MX215 | Eizo RadiForce<br>RS210 | Explanation of<br>Differences | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Display Performance/Specifications | | | | | Screen<br>technology | TFT Monochrome LCD<br>Panel (IPS) | TFT Monochrome LCD<br>Panel (IPS) | | | Viewing<br>angle (H, V) | H: 178°, V: 178° | H: 170°, V: 170° | Eizo uses typical data for<br>very low contrast<br>provided by the panel<br>manufacturers | | Active screen<br>size | 324.0 mm x 432.0 mm | 432.0 mm x 324.0 mm | | | Resolution | 2MP (1,200 x 1,600) | 2MP (1,600 x 1,200) | | | Aspect ratio | 3 : 4 | 4 : 3 | | | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | | | Maximum<br>luminance | 420 cd/m² | 300 cd/m² | | | DICOM<br>calibrated<br>luminance | 180 cd/m² | 150 cd/m² | | | Contrast ratio | 1500 : 1 | 1000 : 1 | Eizo uses typical contrast<br>ratio data provided by<br>panel manufacturers. | | Backlighting | LED | CCFL | See main text. | | Display<br>Colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77<br>million colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77<br>million colors | | | Luminance<br>non-<br>uniformity<br>compensation | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | | | Video Signal Input | | | | | Input video<br>signals | DVI-I x 1,<br>DisplayPort x 1 | DVI-I x 2 ,<br>DisplayPort x 1 | | | Scanning<br>Frequency<br>(H, V) | Digital : 31 - 76 kHz / 59<br>- 61 Hz (VGA Text: 69 -<br>71 Hz)<br>Analog : 26 - 80 kHz / 49<br>- 76 Hz | Digital : 31 - 100 kHz /<br>59 - 61 Hz (VGA Text:<br>69 - 71 Hz)<br>Analog : 31 - 100 kHz /<br>49 - 86 Hz (1600 x 1200:<br>49 - 61 Hz) ,<br>Frame synchronous<br>mode: 59 - 61 Hz | | | Power Related Specifications | | | | | Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | - | | Power<br>Consumption<br>/ Save Mode | 48 W / Less than 0.5 W | 64 W / Less than 1 W | - | | Power<br>Management | Digital: DVI DMPM,<br>DisplayPort 1.1a<br>Analog: VESA DPM | Digital: DVI DMPM,<br>DisplayPort 1.1a<br>Analog: VESA DPM | - | | Miscellaneous Features/Specifications | | | | | QC software | RadiCS | RadiCS | - | | Sensors | Backlight Sensor (BS),<br>Integrated Front Sensor (IFS),<br>Presence Sensor (PS) | Backlight Sensor | Among two sensors not<br>implemented on RS210,<br>only the IFS has<br>something to do with the<br>maintenance or the<br>calibration; the PS detects<br>the absence of the user to<br>trigger the power saving<br>mode of the monitor.<br>The IFS enables<br>automatic grayscale<br>calibration by measuring<br>the luminance at the<br>screen surface. | | USB Ports /<br>Standard | 1 upstream,<br>2 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | - | | Dimensions<br>w/o stand<br>(W x H x D) | 360 x 485 x 64 mm | 472 x 373 x 69 mm | Different housing design<br>due to the different panel<br>size | {3}------------------------------------------------ For the substantial equivalence determination, only the difference of the backlight technologies needs further evidences by performance testing. . : : {4}------------------------------------------------ K131090 Page 5 of 6 # 9. Performance Testing The following bench tests were performed on the RadiForce MX215. - Verification of the conformance to DICOM GSDF as specified in Assessment of Display . Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline) - . Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline - Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline - Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions - Visual check of presence or absence of miscellaneous artifacts on the display screen as ● specified in the TG18 guideline - The maximum number allowed for each type of pixel defects/faults . The test results showed that the RadiForce MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210. Besides, the display characteristics of the RadiForce MX215 meet the pre-defined criteria when criteria are set. No animal or clinical testing was performed on the RadiForce MX215. #### 10.Conclusion The 2MP Color LCD Monitor, RadiForce MX215 has the same intended use as the predicate device but has one different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce MX215 was not affected by the difference of the technological characteristics. Therefore, the RadiForce MX215 was determined to be substantially equivalent to the predicate device. {5}------------------------------------------------ ### DEPARTMENT OF BEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three wings. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-C1609 Silver Spring, MD 20993-0002 July 3, 2013 EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano. Hakusan lshikawa 924-8566 JAPAN Re: K131090 Trade/Device Name: 2MP Color LCD Monitor, RadiForce MX215 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: April 18, 2013 Received: May 2. 2013 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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful.and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Hashimoto 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Jaming M. Menge Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K 131090 Device Name: 2MP Color LCD Monitor, RadiForce MX215 Indications for Use: This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It 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 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Ramingh. Hess. (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health > K131090 510(k) Page 1 of 1