← Product Code [LLZ](/productcode/LLZ) · K092328 # MED-SEG, MODEL BTMS 1000 (K092328) _Bartron Medical Imaging, Inc. · LLZ · Jul 26, 2010 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K092328 ## Device Facts - **Applicant:** Bartron Medical Imaging, Inc. - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Jul 26, 2010 - **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 MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis. Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography. ## Device Story MED-SEG is a PACS software for radiological image management; receives digital images from CT, MR, US, RF, and radiographic sources via secure internet links. System utilizes parallel-computing algorithms to perform high-speed segmentation and regionalization of 2D images; allows users to colorize and label specific regions; assists in finding window/level settings and report generation. Operated by trained professionals (physicians, radiologists, nurses, technicians) in clinical settings. Output displayed on monitors for review; does not provide primary diagnosis. Benefits include enhanced visualization and workflow efficiency for image analysis. System does not contact patients or control life-sustaining equipment; clinician retains final decision-making authority. ## Clinical Evidence No clinical data. Laboratory testing documented compliance with recognized consensus standards for radiological image processing systems. ## Technological Characteristics PACS software for image processing, storage, display, and communication. Features parallel-computing algorithms for high-speed segmentation and regionalization. Connectivity via secure internet link. DICOM compliant. Does not contact patient; no life-sustaining control. Software-based. ## 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 - DEMASQ Imaging Software ([K090481](/device/K090481.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}------------------------------------------------ MEDICAL IMAGING INC RTH A THOUSAND WORDS # 510 (k) SUMMARY # Bartron Medical Imaging MED-SEG™ System JUL 26 2010 KO92328 P. 1082 Submitter's Name, Address, Telephone Number, Contact Person and Date Prenared: | Prepared: | | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Bartron Medical Imaging, Inc.
1100 Mercantile Lane, Ste 115A
Largo, MD 20774
Telephone: (301) 583-4642 /x243
Facsimile: (301) 772-8540 | | Contact Person: | Zvi Ladin, PhD.
Principal
Boston MedTech Advisors, Inc.
990 Washington Street
Suite #204
Dedham, MA 02026
Telephone: (781) 407 0900 x104
Facsimile: (781) 407 0901
Email: zladin@bmtadvisors.com | | Date Prepared: | July 12, 2010 | | Name of Device and Name/Address of Sponsor | | | Trade/Proprietary Name: | MED-SEG™ | | Common Name: | Picture Archiving and Communication System | | Classification Name: | System, Image Processing, Radiological | | Regulatory Class: | II | | Product Code: | LLZ | | Federal Regulation: | 21 CFR §892.2050 | | Manufacturing Facility: | Bartron Medical Imaging, Inc.
91 Shelton Street
New Haven, CT 06511
Telephone: (203) 498-2184
Facsimile: (203) 498-2189 | | Establishment Registration Number: | N/A | | Owner/operator number: | N/A | {1}------------------------------------------------ AEDICAL IMAGING INC H A THOUSAND WORDS ### Predicate Device DEMASQ Imaging Software, manufactured by DEMASQ Ltd of Wales, United Kingdom and cleared under 510(k) #K090481 on March 19, 2009. #### Intended Use / Indications for Use MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis. Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography. #### Technological Characteristics MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication. The system can receive digital images via a secure internet communication link. The system incorporates parallel-computing algorithms that perform high-speed segmentation and regionalization. The system does not contact the patient nor does it control any life sustaining devices. A clinician interprets the images and information displayed by the system. providing ample opportunity for human intervention in the clinical decision process. #### Performance Data Laboratory testing documented that MED-SEG™ complies with the recognized consensus standards for radiological image processing systems. #### Substantial Equivalence MED-SEG™ is a PAC system that uses the same software technology, and complies with the same recognized consensus standards as its predicate device. It has the same intended use and indications for use as the predicate system and therefore is substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle. ## 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 Bartron Medical Imaging, Inc. % Zvi Ladin, Ph.D. Principal Boston Medtech Advisors, Inc. 990 Washington Street, Suite 204 DEDHAM MA 02026 JUL 2 6 2010 Re: K092328 Trade/Device Name: MED-SEGTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2010 Received: February 16, 2010 #### Dear Dr. Ladin: 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. Isting 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 (reporting of {3}------------------------------------------------ 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 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, 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 809), please contact the Office of 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 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/cdrh/industry/support/index.html. Sincerely yours, Donald J. Trump Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use # JUL 2 6 2010 510(k) Number (if known): K092328 | Device Name: | MED-SEG™ | |--------------|----------| |--------------|----------| Indications For Use: MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis. Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography. Prescription Use (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, @ffice of Beview Evaluation (ODE) OTV( signature (Division Sign-Of Division of Raulological Devices Office of In Vitro Diagnostic Devices Exaluation and Safety 510K K692328 Page 1 of --- **Source:** [https://fda-staging.innolitics.com/device/K092328](https://fda-staging.innolitics.com/device/K092328) **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. 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