← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K050667 # R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE (K050667) _R2 Technology, Inc. · LLZ · Mar 29, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050667 ## Device Facts - **Applicant:** R2 Technology, Inc. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Mar 29, 2005 - **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 ## Indications for Use The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices. ## Device Story R2 Image Display Units consist of off-the-shelf personal computers, Windows-based CPUs, and monitors. The system utilizes Uniform Display Software (UDS) to provide a user interface for viewing medical images and CAD-generated marks. The device is intended for non-diagnostic display of images and pre-computed annotations. It supports DICOM protocols for communication with medical scanning devices. The system is used in clinical environments to assist healthcare providers in reviewing pre-computed regions-of-interest or CAD marks, facilitating clinical workflow by presenting these findings alongside the source images. ## Clinical Evidence Bench testing only. The device will undergo design verification tests to ensure conformance with functional specifications. ## Technological Characteristics Off-the-shelf personal computer hardware; Windows-based CPU; hard drive; various monitor sizes with identical functional specifications. Connectivity via DICOM protocol. Software-based display system. ## 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 - R2 CT ImageChecker for CT ([K023003](/device/K023003.md)) - ICAD Second Look Viewer ([K042697](/device/K042697.md)) - MiraMedica Consultiva ([K031248](/device/K031248.md)) - RadX, Mammolux Changers ([K800751](/device/K800751.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}------------------------------------------------ K050667 R2 Technology, Inc. R2 Image Display Units with Uniform Display Software (UDS) 510(k) Premarket Notification February 7, 2005 CONFIDENTIAL Section B-I Summary MAR 2 9 2005 ### 510(k) Summary Prepared February 7, 2005 - R2 Technology, Inc. Submitted by: 1195 W. Fremont Avenue Sunnyvale, CA 94087 Richard Ball, Director of Regulatory Affairs Contact Person: - R2 Family of Image Display Units with Product Name: R2 Uniform Display Software (UDS) Medical Imaging Workstation Common Name: LLZ; Class II; CFR 21 892.2050 Classification: | Predicate Devices: | K023003 | R2 CT ImageChecker for CT | |--------------------|---------|---------------------------| | | K042697 | ICAD Second Look Viewer | | | K031248 | MiraMedica Consultiva | | | K800751 | RadX, Mammolux Changers | # Description of Device: The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications. R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features # Intended Use: The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices. # Comparison with Predicate Devices: The Submission device and the predicate devices have the same intended use and equivalent technological specifications. All devices support DICOM protocol for communication of images and other medical imaging devices. ### Studies: The family of Image Display Units with UDS Software will undergo design verification tests for conformance with specifications. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 R2 Technology, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K050667 MAR 2 9 2005 Trade/Device Name: R2 Family of Image Display Units with Uniform Display Software (UDS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 10, 2005 Received: March 15, 2005 Dear Mr. Christensen: 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. 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. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket notification. The FDA miding of sacsantial of a former 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 spective advice for your device of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note tic regulation entitled, "Albertation on your responsibilities under the Act from the 807.97). You may other general mierrational 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/industry/support/index.html. Sincercly 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 {3}------------------------------------------------ R2 Technology, Inc. R2 Image Display Units with Uniform Display Software (UDS) 510(k) Premarket Notification February 7, 2005 CONFIDENTIAL Section B-II Indications For Use Device Name: R2 Family of Image Display Units with R2 Uniform Display Software (UDS) The family of R2 Image Display Units with UDS software is intended to display low The failiny of RD images Displaysal images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks from medical scanning devices. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) - Harry C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, B-3 and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050667](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050667) **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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