← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K070397 # DGSCOPE, RELEASE 1.0 (K070397) _Segami Corporation · LLZ · Apr 13, 2007 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K070397 ## Device Facts - **Applicant:** Segami Corporation - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Apr 13, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images. ## Device Story DGSCOPE Release 1.0 is a software-based medical image review system; inputs DICOM-formatted diagnostic images from multimodality sources (radiological systems, PACS, workstations); displays images on an integrated PC in planar and pseudo-3D formats; supports static and dynamic review modes. Designed for use in clinical settings, including operating rooms, by healthcare professionals. PC surfaces are compatible with FDA-approved liquid disinfectants. Output facilitates clinical review and decision-making by providing visualization of diagnostic data. Does not perform primary diagnosis for mammography. ## Clinical Evidence No clinical data provided; device is a software-based image review system for DICOM data. ## Technological Characteristics Software-based image review system; operates on an integrated PC; supports DICOM standard; displays planar and pseudo-3D images; compatible with liquid disinfectants for OR use. ## 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). ## 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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine, and the logo is used to represent the U.S. government agency responsible for protecting the health of all Americans and providing essential human services. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Philippe Briandet Ph.D. President Segami Corporation 8325 Guilford Road, Suite B COLUMBIA MD 21046 Re: K070397 Trade/Device Name: DGSCOPE, Release 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 9, 2007 Received: February 12, 2007 Dear Dr. Briandet: 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 (Premarket Approval), 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. Image /page/0/Picture/9 description: The image shows a logo with the text "1906-2006 FDA Centennial" inside a circular border. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text below the logo emphasizes the organization's mission to safeguard and improve public health. {1}------------------------------------------------ Page 2 - Please be advised that FDA's issuance of a substantial equivalence determination does not mean i toase be actised that I Drinination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in and quants by evelop 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) I his letter will anow you to bogan finding of substantial equivalence of your device to a legally prematicated predicated 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 If you desire specific ac a cone of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 CF 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/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {2}------------------------------------------------ PREMARKET NOTIFICATION 510(k) Product Name: DGScope 510(k) Number (if known): K070397 Device Name: DGSCOPE, Release 1.0 ## Indications for Use: The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K070397 | OR | Prescription Use |
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| Over-The-Counter Use | | |----------------------|--------------------------------------------|--------------------------|--| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | | Appendix II-2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K070397](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K070397) **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