RADSPA

{0}------------------------------------------------ ### JUN 2 0 2014 K141329 page 10 of 15 Image /page/0/Picture/2 description: The image shows the logo for Telerad Tech. The logo consists of a circle with the letters "T" and "2" inside, and the words "Telerad Tech" to the right of the circle. Below the words "Telerad Tech" are the words "Smarter Healthcare On Demand". The logo is black and white. Telerad Tech Private Limited 510(k) Summary Annexure 05 ### Date prepared: 1st February 2013 Submitter information: 807.92(a) (1) Mr. Ricky Bedi, CEO TELERAD TECH Private Limited Plot # 7G, Vishveshwaraiah Industrial Area. Whitefield, Bangalore- 560048, India. Tel: +91-80-40187500, Email: ricky.bedi@teleradtech.com ### Name and classification of device: 807.92(a)(2) Trade name: RADSpa™ Common Name: Picture Archive Communication System (PACS) Classification name: system, Image processing, Radiological Class: Class II Product code: LLZ Regulation number: 892.2050 ### Predicate device: ### For RADSpa™ MPR/MIP/3Dapplication: Manufacturer: Calgary Scientific, Inc. Trade name: ResolutionMDTM 2.1 Common name: Picture Archive Communication System (PACS) 510(k) number: K082693 Classification name: system, Image processing, Radiological Class: Class II Product code: LLZ Regulation number: 892.2050 ### For RADSpa™ PACS and Viewer: Manufacturer: eRAD Inc. Trade name: eRAD PACS Common name: Picture Archive Communication System (PACS) 510(k) number: K061421 Classification name: PACS Class: Class II Product code: LLZ {1}------------------------------------------------ 510(k) Summary Annexure 05 Requlation number: 892.2050 ### Device description: 21 CFR 807.92 (a)(4) RADSpa™ is a software device that consists of RADSpa™ PACS and Viewer&RADSpa™ 2D/MPR/MIP/3D viewer. RADSpa™ PACS components (server-side) enable receiving, storing and sending DICOM images and managing the workflow required for radiologists. The components are developed using .NET and runs on Windows OS. The images are stored in the file system and the workflow-related data in a RDBMS database RADSpa MPR/MIP/3Dviewer components run on Windows OS and enable downloading of images from RADSpa™ server and viewing and manipulating of those images on the workstation Overall features include: - . Centralized or Distributed Archive functionality - Uses commercially available computers, servers, operating systems and network . infrastructure, with expandable storage capability - Single or Multi server options (i.e. Archive, Web Server and PACS application can ◆ reside on a single server computer) - Pre-emptive downloading- perfecting of images in real time Web based solution . - Scalable from single practice to enterprise wide PACS . - High level of security . - DICOM, JPEG and JPEG 2000 compliant . {2}------------------------------------------------ 510(k) Summary Telerad Tech" elerad Tech Private Limited Annexure 05 # Substantial Equivalence Comparisons to Predicate Device ### PACS and viewer | Features | Subject device: RADSpa™ PACS and<br>Viewer | Predicate device: eRAD | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. | eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. | | | RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices. | | {3}------------------------------------------------ nnexure 0 erad Tech Private Limite 0(k) Summa erad Tec disk GB 200 core processor, 4GB RAM, ice, Gigabit Ethernet port RHEL Yes Yes Yes Yes Yes Yes Yes Yes Yes core processor, 4GB RAM, 200 GB Vindows ce, Gigabit Ethernet por yes yes yes yes yes yes yes yes yes . " . mputer operating syst utomatically receive COM images from an Distribution of images data via internet and nternet and Intranet dividual user templat oss sectional viewin Web-delivered viewing software omputer platform Inimum requiremen ICOM/HL7 interfac apabilities ecure administratio nage review and lain film studies w.teleradtech.co Page 4 of 15 {4}------------------------------------------------ | | Telerad Tech Private Limited | | |-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Image: Telerad Tech logo<br> | 510(k) Summary | Annexure 05 | | Image measurement tools | yes | Yes | | Image compression | yes | Yes | | Modality support | All Modalities | All Modalities | | Networking communication protocol | TCP/IP | TCP/IP | | Standard interfaces | DICOM/ HL7/ HTTP/ HTTPS | DICOM/ HL7/ HTTP/ HTTPS | | Image storage | Yes | Yes | | Image: Telerad Tech logo | 510(k) Summary | Annexure 05 | | RADSpaTM Viewer | | | | Receive, store, retrieve, display and process digital medical images | | Yes | | Display of clinical patient data when no access to work station | | Yes, Web based | | Multi Planar Reconstruction (MPR) and 3D image rendering | | Yes | | Maximum Intensity Projection (MIP) | | Yes | | Distance measurements | | Yes | | Standardized Uptake Value (SUV) | | Yes | | Zoom/pan | | Yes | | User authentication | | Yes | | Modalities | | All | | Operating platform | | Windows 2000 onwards | | Hardware requirements | | Operating System: Microsoft Windows ALL VERSIONS<br>Processor speed: greater than 2GHz<br>RAM: 4 GB<br>Recommended viewing conditions | | Image: Telerad Tech logo<br>Telerad Tech<br>Crow Homoure On DerTICT<br>ты | Telerad Tech Private Limited<br>510(k) Summary<br>Annexure 05 | | | Video RAM: minimum of 256MBs Support for Direct X v9.0 drivers dated August, 2008 or more recently Support for Pixel Shader 2.0 or later. | Video RAM: minimum of 256MBS Support for Direct X v9.0 drivers dated August, 2008 or more recently Support for PixelShader 2.0 or later. Operating system: Microsoft Windows ALL VERSIONS | | : . : www.teleradtech.com . . . {5}------------------------------------------------ Annexure 05 510(k) Summary Telerad Tech : . elerad Tech Private Limited Page 6 of 15 {6}------------------------------------------------ · : Page 7 of 15 . {7}------------------------------------------------ 10(k) Summary Telerad Tech" Annexure 05 ## RADSpa™ MPR / MIP/3D | | Features | Subject : RADSpa™ MPR / MIP/3D | Predicate Device: Resolution MD™2.1 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Intended use/ indications for use | RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images.<br>This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points.<br>RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The | The Resolution MD™ 2.1 is a software-based Picture Archiving and Communication System (PACS) used with general-purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various; sources including CT and MRI.<br>The ResolutionMD™ 2:1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on non contrast enhanced cardiac CT | | Image: Telerad Tech logo | Telerad Tech Private Limited | Annexure 05 | | | | 510(k) Summary | | | | | software package includes tools to<br>allow the radiologist to manipulate and<br>fly-through images for enhanced<br>visualization.<br>RADSpa™ MPR/MIP/3Dis not intended<br>for mobile devices. | data sets. It also includes the<br>Coronary Artery Analysis protocol<br>which is used to visually identify<br>and measure stenosis in the<br>coronary arteries. This protocol is<br>performed on contrast-enhanced<br>cardiac CTA data sets.<br>The ResolutionMD™2.1 software<br>is intended for use as a<br>diagnostic, review, and analysis<br>tool by trained professionals such<br>as physicians, technologists, and<br>nurses. When interpreted by a<br>trained physician, reviewed<br>images may be used as an<br>element for diagnosis. It is the<br>user's responsibility to ensure<br>that the software is installed on<br>appropriate hardware and that<br>image quality is suitable for the<br>clinical application. Calgary<br>Scientific recommends that users<br>of the ResolutionMD™2.1 | | {8}------------------------------------------------ Page 9 of 15 e915 {9}------------------------------------------------ | Image: Telerad Tech logo | Telerad Tech Private Limited | | |--------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Telerad Tech | 510(k) Summary | Annexure 05 | | | | software consult the appropriate<br>American College of Radiology<br>Practice Guidelines pertaining to<br>the anatomy and pathology being<br>studied.<br>Lossy compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary image interpretations.<br>Mammographic images may only<br>be interpreted using an FDA<br>approved monitor that offers at<br>least 5 Mpixel resolution and<br>meets other technical<br>specifications reviewed and<br>accepted by FDA. | Page 10 of 15 {10}------------------------------------------------ 510(k) Summary Telerad Tech ನ್ನು ಸ . " Annexure 05 | 2D Features | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----| | Cross sectional imaging presents a wide array of<br>Image manipulation possibilities.<br>Being able to reconstruct multiple planes from a<br>single CT or MR dataset provides the reporting<br>physician the ability to view anatomical structures<br>from different aspects. Maximum Image<br>Projection views for better evaluation of vascular<br>structures.<br>The WL settings are carried over to the MPR or<br>MIP from the 2D display or the user can apply<br>presets to the reconstructed images. | yes | Yes | | All features of 2D | yes | Yes | | Slab MPR (Up To 393.8 mm) with Custom<br>entry: | yes | Yes | | The data set is rendered with a user defined slab<br>thickness for rapid and flexible reporting of large<br>datasets. As part of the workflow all views<br>automatically adjust to the newly applied<br>thickness. Users see this rendering in real time,<br>with server-grade performance. | yes | Yes | | MIP, minIP, Average Slab Rendering:<br>Allows the users to adjust the settings for various<br>rendering displays to see different anatomy and<br>pathology. | yes | Yes | | Orthogonal and Oblique MPR: User can change<br>the origin and orientation of the displayed MPR<br>slices by manipulating Image Cursor tool. This<br>feature allows you to inspect any region of<br>interest using the three-sided oblique MPR view. | yes | Yes | | MIP - Using maximum intensity projection (MIP)<br>for re-sampling basically gives the maximum | yes | Yes | www.teleradtech.com Page 11 of 15 {11}------------------------------------------------ | Image: Telerad Tech logo | Telerad Tech Private Limited | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------|--| | | 510(k) Summary | Annexure 05 | | | extent of high attenuation objects within the slab<br>From the current viewing direction. Another<br>advantage of MIP re-sampling is an increase of<br>spatial orientation since dense side objects may<br>become visible. | | Yes | | | MinMIP - Analogously the minimum intensity re-<br>sampling method (MinMIP) is intended to<br>emphasize structures of low attenuation. | | Yes | | | RaySum - Averaging the voxels projected to one<br>pixel in image space naturally results in blurred<br>images. Especially tiny structures tend to fade out<br>as well as calcified parts may decrease<br>attenuation. However especially for data sets with<br>low signal noise ratio this kind of re-sampling<br>improves the image quality. | | Yes | | | CPR: Curved planar reformations are two-<br>dimensional images that may be used to trace<br>the course of an anatomic structure through the<br>entire data set. Curved planar reformations can<br>delineate a curved path and display the whole<br>course of an anatomy in a single cross- section<br>image according to a manually drawn curved line. | | Yes | | | 3D Features : | | | | | 2D Features included<br>Collaboration, Pan, Window Width/Level, Linear<br>measurement, Zoom, WL Presets Text<br>Annotation, Keyboard Shortcuts, Screenshot,<br>Reset To Original View Settings | | Yes | | | 3D visualization template: Predefined<br>visualization templates are designed to point out<br>object of interest such as bones, vessels, skin,<br>lungs, etc. precise tools for adjusting visualization<br>templates, creating new templates and saving<br>them for further use. | | Yes | | . . www.teleradtech.com . . Page 12 of 15 ・ {12}------------------------------------------------ | Image: Telerad Tech logo | 510(k) Summary | Annexure 05 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------| | 3D Tools: Trimming: Trimming the image<br>enables you to expose your region of interest or<br>remove certain parts of the image. Since the<br>region of interest can be Considerable smaller<br>then original image. | yes | Yes | | Thin Slab/Oblique Trim: Trim Mode is very<br>efficient and easy to use, but it can only trim<br>rectangle/orthogonal regions. Thin Slab tool<br>enables you to display only the region between<br>two parallel planes orientated in any direction –<br>this region is called Thin Slab. | yes | Yes | | Sculpting: To remove an arbitrary region from a<br>3D image, use the Sculpting tool. Sculpting tool<br>enables you to define a region on the 3D window<br>and remove all the data that lies within<br>boundaries of that region. | yes | Yes | | 3D Flythrough: current position of the camera<br>and the target at which the camera is looking at.<br>User can drag the camera and the target to a new<br>position. | yes | Yes | . vww.teleradtech.com Page 13 of 15 {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows a logo for a company called "Telera". The logo consists of a circle with the letter "T" and the number "2" inside it. Below the letter and number are some lines that look like rays. To the right of the circle is the word "Telera" in a sans-serif font, with the words "Smarter Health" below it in a smaller font. 510(k) Summary Annexure 05 ### Intended use:21 CFR 807.92 (a)(5) RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information. ### RADSpa™ PACS and Viewer RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices. ### RADSpa™ MPR/MIP/3D RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points. RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization. RADSpa™ MPR/MIP/3Dis not intended for mobile devices. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the text "Telerad Tech Private Limited" in bold, black font. The text is displayed on a white background. The words are arranged in three lines, with "Telerad Tech" on the first line, "Private" on the second line, and "Limited" on the third line. 510(k) Summary Annexure 05 ### Technological characteristics: 21 CFR 807.92 (a)(6) The device does not contact the patient, nor does it control any life sustaining devices. A specialised physician interprets the images and information being displayed and printed. ### Conclusion: 21 CFR 807.92 (b) The 510(k) Pre-Market Notification for RADSpa™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be developed in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor". {15}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 20, 2014 TELERAD TECH Private Limited % Manoj Zacharias President Liberty Management Group Ltd. 2871 Coastal Drive AURORA IL 60503 Re: K141329 Trade/Device Name: RADSpaTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 23, 2014 Received: May 21, 2014 Dear Mr. Zacharias: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {16}------------------------------------------------ Page 2-Mr. Zacharias If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours,  Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health for Enclosure {17}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K141329 Device Name RADSpaTM ### Indications for Use (Describe) RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information. ### RADSpa™ PACS and Viewer RADSpaTM PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices. ### RADSpa™ MPR/MIP/3D RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points. RADSpa™ MPR/MIP/3D is also used to perform post-processing andlysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization. RADSpaTM MPR/MIP/3D is not intended for mobile devices. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {18}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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