← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K091687 # PACSMATE, MODEL MMD-4300C/MMD-4300CX (K091687) _Iei Technology Corp. · LLZ · Jul 7, 2009 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K091687 ## Device Facts - **Applicant:** Iei Technology Corp. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Jul 7, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use PACSmate MMD-4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis. ## Device Story PACSmate MMD-4300C/4300CX is a 30-inch monochrome/color LCD medical-grade monitor; 4-megapixel resolution. Used by trained medical practitioners in clinical settings to display and view digital diagnostic images (X-ray, MRI). Device receives digital image data from external imaging systems; displays images for clinical review and diagnostic decision-making. Does not support mammography imaging. ## Clinical Evidence Bench testing only; no clinical data provided. Device conforms to IEC 60601-1 and IEC 60601-1-2 standards for safety and EMC. ## Technological Characteristics 30-inch monochrome/color LCD monitor; 4-megapixel resolution. Conforms to IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - FLEXSCAN MX300W ([K073340](/device/K073340.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JUL - 7 2009 ## 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 #### 1. Submitter's Name: IEI Technology Corp. Address: No.29,Jhong-Sing Road, Si-Jhih City, Taipei County, 221, Taiwan Phone: +886-2-26902098 EXT: 18853 Fax: +886-2-26902099 Mr. Tom Chen Contact: ### 2. Device Name : | Trade Name: | PACSmate | |---------------------|---------------------------------------------------------------------------------------| | Model no.: | MMD-4300C/MMD-4300CX | | Common Name: | Image display system, medical image workstation, image
monitor/display, and others | | Classification name | System, image processing, radiological | - 3. DEVICE CLASS ## The PACSmate MMD-4300C/4300CX has been classified ક્ષક Regulatory Class: II Panel: Radiology Product Code: LLZ Regulation Number: 21CFR 892.2050 - The predicate device is the COLOR LCD MONITOR, 4. Predicate Device: FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION. - PACSmate MMD-4300C/4300CX is intended to be used in 5. Intended Use: displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis. ### Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary 26 REV. 【A】 Page 1 of 2 Section 4 – 510(k) Summary {1}------------------------------------------------ # 6. Device Description: The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions. - 7. Performance In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards Summary: included IEC 60601-1 and IEC 60601-1-2 requirements. #### 8. Conclusions: The PACSmate MMD-4300C/4300CX has the same intended use and similar technological characteristics as the COLOR LCD MONITOR, FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The PACSmate MMD-4300C/4300CX is substantially equivalent to the predicate devices. #### Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary Page 2 of 2 REV. [A] 27 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL - 7 2009 IEI Technology Corp. % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. (USA) 2904 N. Boldt Drive FLAGSTAFF AZ 86001 Re: K091687 Trade/Device Name: PACSmate, Model No .: MMD-4300C/MMD-4300CX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2009 Received: June 10, 2009 ### Dear Ms. Reich: 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 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 {3}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours Shurly M. Morris 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 (if known): Device Name: PACSmate Model No.: MMD-4300C/MMD-4300CX IEI Technology Corp. Indications For Use: PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis. Prescription Use V (Parl 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) Page 1 of 1 Division Rign Off (Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number 24 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K091687](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K091687) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com