← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K063153 # NOVAPACS (K063153) _Novarad Corp. · LLZ · Dec 7, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K063153 ## Device Facts - **Applicant:** Novarad Corp. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Dec 7, 2006 - **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 product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis. ## Device Story NovaPACS is a Picture Archiving and Communication System (PACS) for digital medical image management. It receives images and data from imaging modalities; stores them in a redundant digital archive (on-site RAID 5 and off-site corporate backup); and provides a web-based interface for access by radiologists, technologists, and referring physicians. The system runs on off-the-shelf hardware within a radiology department LAN. Radiologists use viewing tools—window/level, zoom, pan, ROI, digital subtraction, ejection fraction, cross-localization—to interpret images and dictate reports. For mammography, the system supports DICOM presentation and volumetric measurements, requiring 5MP LCD monitors for primary diagnosis. The device replaces film-based workflows with digital storage and retrieval, facilitating clinical decision-making through improved image accessibility and redundant data preservation. ## Clinical Evidence No clinical data. Bench testing only. The device is a software-based image management system that does not alter or analyze clinical images. ## Technological Characteristics Software-based PACS residing on off-the-shelf hardware; utilizes DICOM standard for image presentation; supports lossless compression for mammography; requires 5MP LCD monitors for mammography interpretation; redundant storage via RAID 5 configuration. ## 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 - Kodak DirectView (Carestream) PACS ## 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}------------------------------------------------ K063153 ## 510K Summary ## NovaRad Corporation DEC - 7 2006 NovaRad Corporation, located at 758 E. Utah Valley Dr., Ste 200 in American Fork, UT 84003 is submitting its PACS product. The contract person is Paul Shumway. The name of the device is PACS. It is a class 2 device under 892.2050. The trade name is NovaPACS. This device is being represented as substantially equivalent to the Kodak DirectView (Carestream) PACS product, a class 2 device under 892.2050. The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 31d party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network. The general use of this device is to be used to read images and information from modalities and store this data so that it can be easily retrieved. As compared to the predicate device, ignoring dissimilarities of hardware brand and specific tools, menus, shortcuts, usability, desktop appearance, price and data base type, the products are exactly similar. The both provide the exact same ability to replace film with digital and they both perform the exact same functions. Both products could be used interchangeable in most aspects. When a customer is looking at our product compared to the predicate device, they are mostly considering differences in service level, price, and ease of use. There are no clinical tests to compare the two as they are merely software products that . send and store images and information. Since the images are not changed or analyzed by the product there is no safety issue, except possible related to the safety of the archived images. NovaRad has more redundancy than the predicate device in that they store the original images on-site with a redundant RAID 5 configuration and then they have another RAID 5 archive on site as a redundant archive and then NovaRad stores a 3ª multiple redundant copy of each image and accompanying information at its corporate headquarters. {1}------------------------------------------------ Although NovaRad is only a PACS with all the customary tools and features of any other major PACS, the reader may wish to glance at the accompanying brochure to gain a sense of what the product looks like. > : : {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Mr. Paul Shumway Vice President NovaRad Corporation 758 East Utah Valley Drive, Suite 200 AMERICAN FORK UT 84003 DEC - 7 2006 Re: K063153 Trade/Device Name: NOVAPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 21, 2006 Received: November 21, 2006 Dear Mr. Shumway: 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/2/Picture/9 description: The image is a black and white logo or emblem. The logo is circular and contains the text "1906-2006" at the top. Below the text is a large, stylized "PA" with the word "Centennial" underneath. There are three small stars at the bottom of the emblem. The image appears to be a commemorative logo for a centennial celebration. oting Public S {3}------------------------------------------------ Page 2 - 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. 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 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 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/cdrlv/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 {4}------------------------------------------------ ## Statement of Indications of Use ## NovaRad Corporation October 9, 2006 892.2050, class II The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis. *Prescription Use* David R. Ingram (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K063153](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K063153) **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