Sonovision is a software application intended for capturing, viewing, archiving and management of images and study data, acquired from Ultrasound machine and other similar medical imaging systems, when installed on suitable commercial standard hardware.

Sonovision is intended for use by obstetricians, gynecologists, radiologists, ultrasound technicians and cardiologists. The system is designed for use in hospitals, medical imaging labs and medical offices.

Sonovision works as Workstation Software for Ultrasound Image Acquisition, Study Management, Reporting, Sending Studies to PACS Server or Making DICOM CD/DVD.

Device Description

Sonovision is an Ultrasound Imaging Solution/Ultrasound Workstation Software for images Acquisition. Study Management & Reporting.

Sonovision capture's images and video clips from Ultrasound machine and save uncompressed images along with patient information to local database.

Saving, searching and loading Studies into secure local Database .
Save Studies as DICOM File, Image Files(JPG, J2K, TIFF and PNG) & Ultrasound . Reports
Send or Retrieve Studies to PACS Server over the network .
Make DICOM CD or DICOM DVD .
Use computer printer to print ultrasound images .
Image Zooming, Panning, Flipping, Rotating Options .
Add Text Annotations on Images .
Record Video Clips and covert them into DICOM Series/frames .

Sonovision does NOT use lossy (irreversible) compression during image handling, manipulation or storage in local Database (It creates uncompressed TIFF Files). However when user converts images or series to DICOM or other Image formats(like JPG, PNG) manually then it may apply lossy (irreversible) compression on images.

All hardware used by Sonovision 2.0 (Including computer, storage drives, network interfaces, video capture cards, monitors and printers) are commercial off-the-shelf equipment

AI/ML Overview

The provided text from the 510(k) Premarket Notification for Sonovision 2.0 is a summary document primarily focused on demonstrating substantial equivalence to existing predicate devices. It does not contain details about a study to prove acceptance criteria or specific performance metrics in the way typically expected for an AI/ML medical device.

The document describes Sonovision v2.0 as an ultrasound workstation software for image acquisition, review, reporting, and archiving. Its primary functions are:

Capturing images and video clips from ultrasound machines.
Saving, searching, and loading studies into a local database.
Saving studies as DICOM files, image files (JPG, J2K, TIFF, PNG), and ultrasound reports.
Sending or retrieving studies to a PACS server.
Making DICOM CDs or DVDs.
Printing ultrasound images.
Image manipulation (Zooming, Panning, Flipping, Rotating, Text Annotations).
Recording video clips and converting them into DICOM series/frames.

Since this is a software for image handling and not an AI/ML algorithm for image analysis or diagnosis, the type of "acceptance criteria" and "study" described in the prompt's questions (e.g., accuracy, sensitivity, specificity, expert consensus, MRMC studies) are not applicable to this device as presented in the 510(k) summary. The acceptance criteria for such a system would typically revolve around functional performance, data integrity, compatibility, and user interface usability, rather than diagnostic accuracy.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone performance (algorithm only) was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

In summary, the provided 510(k) document for Sonovision 2.0 does not include the type of detailed performance study information typically required for AI/ML diagnostic or prognostic devices as it is an image processing and management system, not a diagnostic algorithm. The "substantial equivalence" demonstration relies on comparing its features and intended use to legally marketed predicate devices, not on a clinical performance study with specific metrics like sensitivity or specificity.

Summary

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Premarket Notification – Sonovision 2.0 an Ultrasound Workstation Software

K113082

510(k) SUMMARY

MAR - 8 2012

FDA/EDRH/DCC

વદન-1-8-2011

RECEIVED

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92

Submitter Information:

.--

Peridot Technologies NY Inc. 9131 Queens Blvd. Suite U, Elmhurst, NY 11373

Date Summary Prepared:

September 1, 2011

Contact Person:

Omar Barlas (Managing Director) Peridot Technologies NY Inc. Telephone: +1-718-424-0633 Email: omar@peridotec.com

Device Name and Classifications:

Trade Name(s):	Sonovision
Version:	2.0
Common Name:	Workstation software for ultrasound image acquisition,review, reporting and archiving.
Classification Name:	Image Processing System
Product Type:	Software Application
Device Classification:	892.2050
Product Code:	LLZ

Intended Use:

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Manufacturer	Device Name	510(k) Number	Clearance Date
AS Software Inc.	AS-OBGYN Information System	K051639	Aug 02, 2005
Ashva TechnologiesPvt. Ltd.	iMagic v2.0	K071602	Jul 23, 2007

Substantial Equivalence:

Device Description:

Sonovision is an Ultrasound Imaging Solution/Ultrasound Workstation Software for images Acquisition. Study Management & Reporting.

Sonovision capture's images and video clips from Ultrasound machine and save uncompressed images along with patient information to local database.

Saving, searching and loading Studies into secure local Database .
Save Studies as DICOM File, Image Files(JPG, J2K, TIFF and PNG) & Ultrasound . Reports
Send or Retrieve Studies to PACS Server over the network .
Make DICOM CD or DICOM DVD .
Use computer printer to print ultrasound images .
Image Zooming, Panning, Flipping, Rotating Options .
Add Text Annotations on Images .
Record Video Clips and covert them into DICOM Series/frames .

All hardware used by Sonovision 2.0 (Including computer, storage drives, network interfaces, video capture cards, monitors and printers) are commercial off-the-shelf equipment

Comparison to Predicated Devices:

Sonovision is substantially equivalent to the following legally marketed devices:

Specification	Sonovision	AS-OBGYN	iMagic v2.0
Image Capturing	YES	YES	YES
Video Capturing	YES	NO	NO
DICOM Conversion	YES	YES	NO
Integration with PACS	YES	YES	NO
Make DICOM CD/DVD	YES	NO	YES
Lossy/Lossless Compression	Lossless (Uncompressed)	Lossy (Compressed)	Lossy (Compressed)
Image Review	Zoom/Pan/Flip/RotateBrightness/Contrast/TextAnnotations	Zoom/Pan	Zoom/Pan/Flip/RotateBrightness/Contrast
Reporting	YES	YES	YES

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAR - 8 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Mr. Omar Barlas Managing Director Peridot Technologies NY Inc. 9131 Queens Blvd. Suite U ELMHURST NY 11373

Re: K113082

Trade/Device Name: Sonovision v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 23, 2012 Received: February 23, 2012

Dear Mr. Barlas:

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 I ca mayy are see 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 that I Drillan intatutes and regulations administered by other Federal agencies. You must or uny 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K113082

Sonovision v2.0 Device Name:

Indications for Use:

Sonovision works as Workstation Software for Ultrasound Image Acquisition, Oorlovision Worke do Womonagement, Reporting, Sending Studies to PACS Server or Making DICOM CD/DVD.

I AOO Ociver of Maning raphic images and digitized film screen images must Eossy oompreeed for primary image interpretation. Mammographic images may not be interpreted using an FDA approved monitor that offers at least 5 Mpixel only be interprotoal dolling an rechnical specifications reviewed and accepted by FDA.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

K113082 Mairy S Patel

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K113082

Page 1 of

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).