iMagic v2.0™ device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.

iMagic v2.0™ receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0™ does not use lossy (irreversible) compression during image handling, manipulation, or storage.

Only DICOM, for presentation, images will be captured for display and diagnosis.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

iMagic, a software application for medical imaging centers, that allows to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email). Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:

. Prevent unauthorized access of Patient Records
Easy search of Patient details .
. Flexibility to design auto patient ID
Report transmission by mail .
. Cropping of live images
Editing of AVI/cine loops
Distribution of Reports and Images in CD .
. Comparison of images between different visits of patient
. Tagging of significant images/cineloops for future references
. Generation of statistical data from available details

AI/ML Overview

The provided text is a 510(k) summary for the iMagic v2.0™ Picture Archiving Communications System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information regarding acceptance criteria, a specific study designed to prove device performance against those criteria, or the specific performance metrics typically found in such studies.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract information relevant to the device description and its intended use.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance:

The document does not report specific quantitative acceptance criteria or detailed device performance metrics that would typically be found in a study demonstrating such criteria. The submission is a 510(k) for a PACS system, which focuses on functional equivalence rather than diagnostic performance metrics like sensitivity, specificity, or AUC as seen in AI/CADe submissions. The "performance" described is in terms of general PACS functionalities and adherence to standards.

Acceptance Criteria Category (Derived from Device Description)	Reported Device "Performance" / Functionality
Data Handling & Viewing	- Records patient details with study information and images
	- Prepares reports for distribution (printout, internet/email)
	- Retrieves images easily
	- Compares images between different visits
	- Distributes patient records in CDs
	- Captures DICOM for presentation, display, and diagnosis
	- Receives images from Ultrasound and other DICOM compliant systems (CT, MR, CR, DR) over network, direct from modality, or archive
	- Utilizes lossless and lossy (irreversible) compression, but does not use lossy during image handling, manipulation, or storage
Security & Workflow	- Prevents unauthorized access of Patient Records
	- Easy search of Patient details
	- Flexibility to design auto patient ID
	- Report transmission by mail
	- Cropping of live images
	- Editing of AVI/cine loops
	- Tagging of significant images/cineloops for future references
	- Generation of statistical data from available details
Regulatory & Safety	- Does not contact the patient
	- Does not control any life sustaining devices
	- Physician interprets images and information, providing opportunity for human intervention
	- Conforms to voluntary standards and hazard analysis (minor concern)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not specified in the provided text. The document does not describe a clinical or performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not specified. Since no clinical test set or ground truth establishment process is described, this information is not present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. No such adjudication method is mentioned as there is no described test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable and not specified. This is a PACS system, not an AI/CADe device designed to assist human readers in diagnosis. Therefore, an MRMC study measuring an AI's effect on human reader performance would not be relevant or expected for this submission, and none is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable and not specified. This is a PACS system, which is an infrastructure for image management and viewing, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified. No ground truth is mentioned as no study involving diagnostic accuracy is described.

8. The sample size for the training set:

Not applicable and not specified. This is a PACS system and would not typically have a "training set" in the context of machine learning algorithms for diagnostics.

9. How the ground truth for the training set was established:

Not applicable and not specified. As above, no training set or ground truth establishment for a training set is relevant to this PACS device or mentioned in the document.

Summary of what the document does describe as proof of meeting acceptance criteria (implicitly):

The document primarily relies on substantial equivalence to a predicate device (Voyager PACS System, K062062). The "study" proving the device meets its (implicit) acceptance criteria is the comparison of technological characteristics and indications for use between iMagic v2.0™ and the predicate device. The conclusion states that "The 510(k) Pre-Market Notification for iMagic v2.0™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This means the device's functionality, safety, and effectiveness are considered to be on par with a device already legally marketed. The submission also mentions adherence to voluntary standards and a hazard analysis classified as "minor."

Summary

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K071602

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: May 19, 2007

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sunder Natrajan, CEO Ashva Technologies Pvt. Ltd., 15 ARK Colony, Urrnilla House Eldams RD. Alwarpet, Chennai India 600018 +11 91 44 420 88897 (fax) sunder@ashvatech.com

JUL 2 3 2007

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	iMagic v2.0™
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ
Device Classification:	892.2050

Predicate Device: 21 CFR 807. 92(a)(3)

iMagic v2.0™ is substantially equivalent to:
Manufacturer:	Voyager Imaging
Device Name:	Voyager PACS Stystem
510(k) Number:	K062062
Product Code:	LLZ
Device Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number:	Class II - 892.2050

Device Description: 21 CFR 807 92(a)(4)

. Prevent unauthorized access of Patient Records
Easy search of Patient details .
. Flexibility to design auto patient ID
Report transmission by mail .
. Cropping of live images

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Editing of AVI/cine loops �
Distribution of Reports and Images in CD .
. Comparison of images between different visits of patient
. Tagging of significant images/cineloops for future references
. Generation of statistical data from available details

Indications for Use: 21 CFR 807 92(a)(5)

Only DICOM, for presentation, images will be captured for display and diagnosis.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images mav only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for iMagic v2.0™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

iMagic v2.0™ has been and will be manufactured 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 3 2007

Ashva Technologies, Pvt. Ltd. c/o Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K071602

Trade/Device Name: iMagic v2.0TM Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2007 Received: June 11, 2007

Dear Mr. Alletto:

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/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in it. The logo has a star at the top and three stars at the bottom. The text is arranged in a circular fashion around the central FDA logo.

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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 mumber at the top of this letter.

21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other

240-276-0115 (Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) 240-276-0115 (Radiology) 240-276-0120 240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(Indications for Use Form)

510(k) Number:

Device Name:

iMagic v2.0

Indications for Use:

Only DICOM, for presentation, images will be captured for display and diagnosis.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use (21 CFR 807 Subpart C)
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(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	2071602
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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).