JUN 2 0 2014

Telerad Tech Private LimitedQm lerad Tc

05 10(k) Summary TAnnexure 05

Date prepared:

1 "t February 2013

Submitter information: 807.92(a) (1)

Mr. Ricky Bedi, CEO

TELERAD TECH Private Limited

Plot # 7G, Vishveshwaraiah Industrial Area.

Whitefleld, Bangalore- 560048, India.

Tel: +91-80-40187500, Email: rickybedi@teleradtech.com

Name and classification of device: 807.92(a)(2)

Trade name: RADSpa TM

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 T M MPR/MIP/3Dapplication:

Manufacturer: Calgary Scientific, Inc.

Trade name: ResolutionMDTM 2.1

Common name: Picture Archive Communication System (PACS)

510(k) number: K(082693

Classification name: system, Image processing, Radiological

Class: Class II

Product code: LLZ

Regulation number: 892.2050

For RADSpa T M PACS and Viewer:Manufacturer: eRAD Inc.

Trade name: eRAD PACS

Common name: Picture Archive Communication System (PACS)

510(k) number: K(061421

Classification name: PACS

Class: Class II

Product code: LLZ

www.te le radtech .com Page 1 of 15

Aft Telerad Tech Private LimitedTelerad Tech'

. -... 510(k) Summary Annexure 05

Regulation number: 892.2050

Device description: 21 CFR 807.92 (a)(4)

RADSpa TM is a software device that consists of RADSpa TM PACS and Viewer&RADSpa TM

2D/MPR/MIP/3D viewer.

RADSpa TM 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 TM 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

www.teleradtech.com Page 2 of 15

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Telerad Tech Private Limited0 f Telerad Tech 510(k) Summary Aneure 05

Intended use:21 CFR 807.92 (a)(5)

RADSpa TM 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.

RADSa T M PACS and Viewer

RADSpa TM PACS is a flexible, standlards-com pliant, 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 T M PACS provides complete PACS functionality used to receive and

manage DICOM images and make the data available across a network. RADSpa TM

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.

RADSna T M MPR/MIP/3D

RADSpa TM MPR/MIP/31D 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 m 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 m MPR/MIP/3Dis not intended for mobile devices.

www.teleradtech.com Page 14 of 15

Telerad Tech Private LimitedTelerad Tech

-a -5 10(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 i mages and information being displayed and printed.

Conclusion: 21 CER 807.92 (b)

The 510(k) Pre-Market Notification for RADSpa T M 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"

www.teleradtech.com Page 15 of 15

*DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Adn,.nssimtaoo0903 New Hampshire Avenue

Document Control Center - W066.G609Silver Spring. MD 2D9934=02

June 20, 2014TELERAD TECH Private Limited% Manoj ZachariasPresidentLiberty Management Group Ltd.2871 Coastal DriveAURORA IL 60503

Re: K141329Trade/Device Name: RADSpaThRegulation Number: 21 CFR 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: 11Product Code: LLZDated: April 23, 2014Received: May 21, 2Q14

Dear Mr. Zacharias:,

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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 premnarke approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

Page 2-Mr. Zacharias

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041or (301) 796-7100 or at its Internet addresshttp://www.fda.Rov/MedicalDevices/ResourcesforYou/lndustrv/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttp):/fwww.fda.gzov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRI's Officeof Surveillance and Biometrics/Division of Postrnarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet addresshttp)://www.fda.gov/MedicalDevices/ResourcesforYou/lndustry/default.htm.

Sincerely yours,

forJanine M. MorrisDirectorDivision of Radiological HealthOffice of In Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

510(k) Number (if known)K 141329

Device NameRADSpaT"

Indications for Use (Descflba)RADSpaTrm components are intended to be used in hospitals, imaging centers, radiologist reading practices and by anyuser who requires and is granted access to view patient's images, demographic and report information.

RADSpTm PACS and Viewer

RADSpaTh PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralizedand distributed imaging environments. This device consolidates all radiology exam information including images andreports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSparhPACS provides complete PACS functionality used to receive and manage DICOM images and make the data availableacross a network. RADSpBTM viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant imagedata derived from all modalities. This component is not intended for mobile devices.

RADSpTm MPRIMIP/3D

RADSpaTrm MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnosticanalysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization andanalysis techniques such as multi-planar and oblique reformats, maximum intensity projections. image averaging,subtraction and blinking of images acquired at different time points.RADSpaTm MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. 'The softwareanalysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensityprojections. The software package includes tools to allow the radiologist to manipulate and fly-through images forenhanced visualization.RAIDSp T m MPR/MIP/3D is not intended for mobile devices.

Type of Use (Select one or both, as applicable)

13Prescription Use (Pert 21 CFR 801 Subpart D) 0] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE 0O NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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