← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K030635 # THE OBSIDIAN PACS SYSTEM (K030635) _Obsidian Medical Technology, Inc. · LLZ · Mar 28, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K030635 ## Device Facts - **Applicant:** Obsidian Medical Technology, Inc. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Mar 28, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device, 3rd-Party Reviewed ## Intended Use The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses. The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements. This device is intended to provide an approximate representation of the 3D volume for use in obstetric exams. ## Device Story Obsidian PACS System connects to analog/digital imaging devices (ultrasound, CT, MRI, digitizer) to acquire, transmit, store, and display patient data. System operates over local area networks or Internet connections. Includes 3D Ultrasound Image Router component that captures 2D ultrasound images and reconstructs them into 3D volumes for obstetric visualization. Operated by trained professionals (radiologists, physicians, technicians, nurses) in clinical settings. Output provides approximate 3D volume representation for obstetric exams; not intended for diagnostic or quantitative use. Healthcare providers interpret displayed images to support clinical workflows. Device does not contact patients or control life-sustaining equipment. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics PACS system for image acquisition, transmission, and storage. Connectivity via LAN or Internet. Supports DICOM standards. Software-based image processing for 3D reconstruction from 2D ultrasound inputs. Non-patient contacting. Minor level of concern for software risk. ## 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 - Echo Tech Easy 3D ([K013088](/device/K013088.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}------------------------------------------------ K030635 Image /page/0/Picture/1 description: The image shows the logo for Obsidian Medical Technology. The logo features the word "OBSIDIAN" in large, bold, sans-serif font, with the words "MEDICAL TECHNOLOGY" in a smaller font size underneath. Above the word "OBSIDIAN" is a graphic of a globe with binary code (1s and 0s) encircling it. 5108 Corona Court · Pleasanton, CA 94588 · tel: (925) 426-3111 · www.obsidianmedical.com ## 510(k) Summary of Safety and Effectiveness Date Prepared: April 22, 2002 Submitter's Information: 21 CFR 807.92(a)(1) Obsidian Medical Technology, Inc. Contact: Bianca Green 5108 Corona Court Pleasanton, CA 94588 Tel: (925) 426-3111 Fax: (925) 426-3001 Trade name, Common Name and Classification: 21 CFR 807.92(a)(2) The Obsidian PACS System Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892 2050 Name: System, Image Processing, Radiology Predicate Device: 21 CFR 892.92(a)(3) Manufacturer: Echo Tech 3D Imaging Systems, Inc. Device: Echo Tech Easy 3D 510(k) Number: K013088 Date Received: 03/06/2002 Decision Date: 04/04/2002 Substantially Equivalent Decision: Panel Code device reviewed by: Radiology Panel Code device classified by:Radiology Product Code: LLZ Class II - 892.2050 Classification: Device Description: 21 CFR 807 92(a)(4) The Obsidian PACS System is comprised of components that connect to an analog or digital medical imaging device (ultrasound, CT, MRI, digitizer), transmit image or patient data, and store image or patient data. The transmission of data can occur internally or externally using a local area network or Internet connection. Indications for Use: 21 CFR 807 92(a)(5) The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses. The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements. This device is intended to provide an approximate representation of the 3D volume for use in obstetric exams. {1}------------------------------------------------ Technological Characteristics: 21 CFR 807 92(a)(6) The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. This device transmits data on and off-site. ## Conclusion: 21 CFR 807 92(b)(3) In accordance with the FDA document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," the level of risk of the Obsidian PACS System was considered to be minor. The documentation submitted on the device system reflects this level of risk and consist of the following documents: - . Architectural design chart - . Hazard analysis - DICOM conformance statement . These documents contain adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device. The Obsidian PACS System will be manufactured in accordance with the standards listed in the enclosed specifications documentation. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 8 2003 Obsidian Medical Technology, Inc. % Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K030635 Trade/Device Name: Obsidian PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 18, 2003 Received: March 20, 2003 Dear Ms. Danielson: 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); 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. {3}------------------------------------------------ Page 2 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon 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): _K & ك ك ك ك ك Device Name: The Obsidian PACS System Indications for Use: The Obsidian PACS System is used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals, including but not limited to, radiologist, physicians, technicians, and nurses. The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements. Prescription Use David R. Seymm (Division Sign-O Division of Reproductive and Radiological D 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K030635](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K030635) **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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