← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K103554 # METRON-CP/MD (K103554) _Eponatech, LLC · LLZ · Dec 20, 2011 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K103554 ## Device Facts - **Applicant:** Eponatech, LLC - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Dec 20, 2011 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use Metron-MD is a clinical software program that is intended to acquire, display, annotate, calibrate, mark-up, analyze, store, print, and distribute medical images using standard PC-compatible computers. Images can be acquired from image files and various image capture devices (e.g. computed radiography devices, digital radiography devices, digital video capture devices, and other imaging devices such as scanners). Metron-MD supports adding notes and other mark-up to images. Using Metron-MD, medical professionals can start with raw images, and quickly and easily produce formatted multi-page reports stored and organized in a searchable database. Metron-MD is not intended to provide medical diagnosis or a recommended treatment approach. ## Device Story Metron-MD is a clinical software application for Windows-based PCs; used by radiologists, orthopedists, chiropractors, and podiatrists. Inputs include medical images/videos from USB cameras, CR/DR systems, digital media, and TWAIN sources. Device performs image acquisition, display, annotation, calibration, mark-up, and measurement. Features include customizable image filtering algorithms to optimize raw image quality. Output consists of processed images and formatted multi-page reports stored in a searchable database. Used in clinical settings to assist practitioners in image review and analysis; does not provide automated diagnosis or treatment recommendations. Benefits include improved image visualization and organized clinical documentation. ## Clinical Evidence Bench testing only. No clinical data provided. Device performance demonstrated through verification of specifications and conformance to DICOM and JPEG standards. ## Technological Characteristics Stand-alone software for Windows XP/7. Supports DICOM 3.0 and JPEG compression. Functions include image processing, measurement, and network transmission. No patient contact; does not control life-sustaining equipment. Relies on human intervention for interpretation. ## 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 - dicomPACS ([K070618](/device/K070618.md)) - Onyx-RAD Telemedicine PACS ([K003607](/device/K003607.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}------------------------------------------------ K103554 P. 1 of 3 #### A. 510(k) Summary DEC 2 0 2011 - 1. Name and Address of Manufacturer John. J Craig, Vice President/Manager EponaTech LLC 6720 Linne Road Paso Robles, CA 93446 (805) 239-3505 #### 2. Establishment registration number K103554 - 3. Name, title and phone number of contact K. Brian Matlock Attorney for Applicant Matlock Law Group, PC 1485 Treat Blvd, Suite 200 Walnut Creek, CA 94597 Phone: (925) 944-7131 - 4. Date Prepared December 5, 2011 - 5. Device Tradename Metron-MD - 6. Device Common Name Picture archiving and communications system (PACS) - 7. Product Code: LLZ - 8. Regulation No. 21 CFR 892.2050 - 9. Device Classification Class II, Image Processing System {1}------------------------------------------------ #### 10. Predicate Devices ---- The Metron-MD imaging software application is substantially equivalent to the following devices. | Manufacturer | Product Name | 510(k) No. | |------------------|-------------------------------|------------| | Oehm and Rehbein | dicomPACS | K070618 | | Viztek, Inc. | Onyx-RAD Telemedicine
PACS | K003607 | ## 11. Device Description Metron-MD is a clinical software program that allows medical professionals to acquire, display, manipulate and archiving medical images. It offers features (e.g. annotation, zoom, calibration, mark-up, measurement, etc.) routinely used by medical professionals, such as radiologists and orthopedists. Metron-MD supports the DICOM standard and accepts file formats including JPEG, Bitmap, TIFF, avi, and DICOM. Metron-MD runs on Windows based PC-compatible computers, accepts existing image files, and captures images and videos from capture devices such as USB video cameras, CR and DR systems, Digital Camera Media, and TWAIN images sources, etc. ## 12. Intended Use Metron-MD is a clinical software program that is intended to acquire, display, annotate, calibrate, mark-up, analyze, store, print, and distribute medical images using standard PC-compatible computers. Images can be acquired from image files and various image capture devices (e.g. computed radiography devices, digital radiography devices, digital video capture devices, and other imaging devices such as scanners). Metron-MD supports adding notes and other mark-up to images. Using Metron-MD, medical professionals can start with raw images, and quickly and easily produce formatted multi-page reports stored and organized in a searchable database. Metron-MD is not intended to provide medical diagnosis or a recommended treatment approach. # 13. Technological Characteristics Metron-MD is a stand-alone software program that runs on Windows based operating system (Windows XP and 7) on any hardware platform meeting the minimum system requirements. Metron-MD allows digital image processing and measurement capability. The program can transmit images to remote viewing stations over a medical imaging network. Metron-MD does not contact the patient, nor does it control any life-sustaining devices. Medical professionals with adequate expert knowledge and ample opportunity for competent human intervention interpret displayed and/or printed images and information. {2}------------------------------------------------ ## 14. Testing Metron-MD is tested according to the specifications documented in this notification. Metron-MD is demonstrated to perform as intended. - 15. Conclusions Metron-MD is a medical device that is substantially equivalent to similar features in the Predicate Devices and has the same intended uses and technological characteristics. The different features included in the Metron-MD software do not affect the safety or effectiveness of the device. This premarket notification contains sufficient information to establish substantial equivalence to the Predicate Devices. ## 16. Applicable Mandatory and Voluntary Standards - Radiation Control for Health and Safety Act a. Not applicable. - b. CDRH Recognized Voluntary Standards - i. DICOM - (1) Metron-MD supports and conforms to the DICOM standard. See Exhibit 1 for "EponaTech Metron-MD DICOM Conformance Statement." (2) Declaration of Conformance Pursuant to Form FDA 3514 (3/08) and in my capacity as Vice President/Manager of EponaTech LLC, I certify that to the best of my knowledge I believe that Metron-MD conforms with DICOM standard Version 3.0. - ii. JPEG Metron-MD supports the JPEG (Joint Photographic Experts Group) standard, which specifies methods for the compression (reversible and irreversible) of digital medical images. John Craig, Vice President 2 DEC. 2011 (Date) (Date) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES :【): Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Epona Tech LLC % Mr. K. Brian Matlock, Esq. Principal Matlock Law Group, P.C. 1485 Treat Boulevard, Suite 200 WALNUT CREEK CA 94597 DEC 2 0 2011 Re: K103554 Trade/Device Name: Epona Tech Metron-CP/MD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 14, 2011 Received: December 15, 2011 Dear Mr. Matlock: - 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements use obegin marketing your device as described in your Section 510(k) premarket with anow you to begin marketing your entil 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 Parts 801 and 11 you don't openite and resident In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 I vision 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/cdrh/industry/support/index.html. Sincerely Yours, Mary S Patel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use Statement ﺎﻳﺔ ﺍﻟﻘ The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and The Eponal econ Metron-Crimib is a cinnoul in chiropractic and podiatry use. Metron-CPMD CR radiography systems, primarily focused on chiropractic and podiate imaging source CK radiography systems, primatily locused on filtering techniques from various imaging standard processes mages using state of the art mir clist review, store, print and distribute using standard and then makes them avanable to display, can, izes the images (radiographs, ultrasounds, PC nardware. Metron-CT NYD stores and organiese and organised for review and analysis by trained photographs, etc), and provides many vario algorithms produce the best image possible from the medical practitioners. Advance mugane migable by the user and organized in Metron-CPMMD's imaging hardware. The filters are custom on and organized in Metron and on searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate searchable database for fact fevrew. Metron of the mages to ald in analysis over time. physical measurements, and producing other mark-ups to al multi nece reports physical measurements, and producing of formatted, multi-page reports. Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intended for mammography use. Metron-CP/MD's features advance imaging algorithms, calibration and measurement tools, Metron-CPMD s leatures advance mule, and full compliance with voluntary Digital Imaging sti multi-imaging suiching, report generation, and running filters are customizable by the users and Communications in Metrone (DCCM) Startiable database for later review. Users then have the and organized in McTor-CF AMD's scaretal reports that can be used in connection with other ability to put together multi-page formatted reports that Can GER AN GER AND 2050 ability to put together mails page sex ments. (See 21 CFR 892.2050) In accordance with 21 CFR 801 Subpart D, the software is intended for prescription use. X Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D) And/Or Over-The-Counter Use: (21 CFR 807 Subpart C) 6 KIDSSEA Michael D. O'Brien 610K 102554 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K103554](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K103554) **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