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 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 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/3D is not intended for mobile devices.

Device Description

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

AI/ML Overview

The provided document is a 510(k) summary for the RADSpa™ system, a Picture Archiving Communication System (PACS) with viewing and post-processing capabilities. While it details the device description, intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, performance study results, or validation methodology (e.g., sample size, expert qualifications, ground truth establishment, or multi-reader multi-case studies) for the RADSpa™ device itself.

The document primarily focuses on establishing substantial equivalence to existing PACS systems (ResolutionMDTM 2.1 and eRAD PACS) by comparing features and intended use. The conclusion states that the submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and mentions a "hazard analysis" and "Level of Concern for potential hazards has been classified as 'minor'". This indicates that the regulatory approval was based on demonstrating equivalence rather than the submission of a new clinical performance study with specific acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample size, data provenance, number of experts, qualifications, or adjudication methods for a test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
Standalone (algorithm only) performance.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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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 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 .

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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 andViewer	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.

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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

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	Telerad Tech Private Limited
Image: Telerad Tech logo	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 VERSIONSProcessor speed: greater than 2GHzRAM: 4 GBRecommended viewing conditions
Image: Telerad Tech logoTelerad TechCrow Homoure On DerTICTты	Telerad Tech Private Limited510(k) SummaryAnnexure 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

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Annexure 05

510(k) Summary

Telerad Tech

: .

elerad Tech Private Limited

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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.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	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.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 toallow the radiologist to manipulate andfly-through images for enhancedvisualization.RADSpa™ MPR/MIP/3Dis not intendedfor mobile devices.	data sets. It also includes theCoronary Artery Analysis protocolwhich is used to visually identifyand measure stenosis in thecoronary arteries. This protocol isperformed on contrast-enhancedcardiac CTA data sets.The ResolutionMD™2.1 softwareis intended for use as adiagnostic, review, and analysistool by trained professionals suchas physicians, technologists, andnurses. When interpreted by atrained physician, reviewedimages may be used as anelement for diagnosis. It is theuser's responsibility to ensurethat the software is installed onappropriate hardware and thatimage quality is suitable for theclinical application. CalgaryScientific recommends that usersof the ResolutionMD™2.1

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e915

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Image: Telerad Tech logo	Telerad Tech Private Limited
Telerad Tech	510(k) Summary	Annexure 05
		software consult the appropriateAmerican College of RadiologyPractice Guidelines pertaining tothe anatomy and pathology beingstudied.Lossy compressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations.Mammographic images may onlybe interpreted using an FDAapproved monitor that offers atleast 5 Mpixel resolution andmeets other technicalspecifications reviewed andaccepted by FDA.

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510(k) Summary

Telerad Tech

ನ್ನು ಸ

. "

Annexure 05

2D Features
Cross sectional imaging presents a wide array ofImage manipulation possibilities.Being able to reconstruct multiple planes from asingle CT or MR dataset provides the reportingphysician the ability to view anatomical structuresfrom different aspects. Maximum ImageProjection views for better evaluation of vascularstructures.The WL settings are carried over to the MPR orMIP from the 2D display or the user can applypresets to the reconstructed images.	yes	Yes
All features of 2D	yes	Yes
Slab MPR (Up To 393.8 mm) with Customentry:	yes	Yes
The data set is rendered with a user defined slabthickness for rapid and flexible reporting of largedatasets. As part of the workflow all viewsautomatically adjust to the newly appliedthickness. Users see this rendering in real time,with server-grade performance.	yes	Yes
MIP, minIP, Average Slab Rendering:Allows the users to adjust the settings for variousrendering displays to see different anatomy andpathology.	yes	Yes
Orthogonal and Oblique MPR: User can changethe origin and orientation of the displayed MPRslices by manipulating Image Cursor tool. Thisfeature allows you to inspect any region ofinterest using the three-sided oblique MPR view.	yes	Yes
MIP - Using maximum intensity projection (MIP)for re-sampling basically gives the maximum	yes	Yes

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Image: Telerad Tech logo	Telerad Tech Private Limited
	510(k) Summary	Annexure 05
extent of high attenuation objects within the slabFrom the current viewing direction. Anotheradvantage of MIP re-sampling is an increase ofspatial orientation since dense side objects maybecome visible.		Yes
MinMIP - Analogously the minimum intensity re-sampling method (MinMIP) is intended toemphasize structures of low attenuation.		Yes
RaySum - Averaging the voxels projected to onepixel in image space naturally results in blurredimages. Especially tiny structures tend to fade outas well as calcified parts may decreaseattenuation. However especially for data sets withlow signal noise ratio this kind of re-samplingimproves the image quality.		Yes
CPR: Curved planar reformations are two-dimensional images that may be used to tracethe course of an anatomic structure through theentire data set. Curved planar reformations candelineate a curved path and display the wholecourse of an anatomy in a single cross- sectionimage according to a manually drawn curved line.		Yes
3D Features :
2D Features includedCollaboration, Pan, Window Width/Level, Linearmeasurement, Zoom, WL Presets TextAnnotation, Keyboard Shortcuts, Screenshot,Reset To Original View Settings		Yes
3D visualization template: Predefinedvisualization templates are designed to point outobject of interest such as bones, vessels, skin,lungs, etc. precise tools for adjusting visualizationtemplates, creating new templates and savingthem for further use.		Yes

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・

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Image: Telerad Tech logo	510(k) Summary	Annexure 05
3D Tools: Trimming: Trimming the imageenables you to expose your region of interest orremove certain parts of the image. Since theregion of interest can be Considerable smallerthen original image.	yes	Yes
Thin Slab/Oblique Trim: Trim Mode is veryefficient and easy to use, but it can only trimrectangle/orthogonal regions. Thin Slab toolenables you to display only the region betweentwo parallel planes orientated in any direction –this region is called Thin Slab.	yes	Yes
Sculpting: To remove an arbitrary region from a3D image, use the Sculpting tool. Sculpting toolenables you to define a region on the 3D windowand remove all the data that lies withinboundaries of that region.	yes	Yes
3D Flythrough: current position of the cameraand the target at which the camera is looking at.User can drag the camera and the target to a newposition.	yes	Yes

vww.teleradtech.com

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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™ PACS and Viewer

RADSpa™ MPR/MIP/3D

RADSpa™ MPR/MIP/3Dis not intended for mobile devices.

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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".

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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.

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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

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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™ 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 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).