(142 days)
Not Found
No
The description focuses on standard image management, archiving, and viewing functionalities without mentioning any AI/ML-specific features or algorithms.
No
The device is a software application for managing and viewing medical images, not for treating or diagnosing conditions directly.
No
Sonovision is described as software for capturing, viewing, archiving, and managing medical images and study data, but it does not perform any analysis or interpretation of the images to diagnose medical conditions. Its functions are related to image handling and storage rather than diagnostic assessment.
Yes
The device is described as a "software application" and "Ultrasound Workstation Software" that runs on "suitable commercial standard hardware" and "commercial off-the-shelf equipment." It does not include any proprietary hardware components.
Based on the provided information, Sonovision is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Sonovision's Function: Sonovision's intended use is to capture, view, archive, and manage images and data acquired directly from medical imaging systems like ultrasound machines. It deals with images generated from within the body, not with analyzing biological specimens taken from the body.
- No Specimen Analysis: The description of Sonovision's functions focuses on image handling, storage, reporting, and communication with other systems (PACS). There is no mention of analyzing biological samples or performing tests on them.
Therefore, Sonovision falls under the category of medical imaging software or a medical image management system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound machine and other similar medical imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: obstetricians, gynecologists, radiologists, ultrasound technicians and cardiologists.
Care Settings: hospitals, medical imaging labs and medical offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
Premarket Notification – Sonovision 2.0 an Ultrasound Workstation Software
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:
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.
1
| Manufacturer | Device Name | 510(k) Number | Clearance Date |
|---|---|---|---|
| AS Software Inc. | AS-OBGYN Information System | K051639 | Aug 02, 2005 |
| Ashva Technologies | |||
| Pvt. 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 .
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
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/Rotate | ||
| Brightness/Contrast/Text | |||
| Annotations | Zoom/Pan | Zoom/Pan/Flip/Rotate | |
| Brightness/Contrast | |||
| Reporting | YES | YES | YES |
2
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
3
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
4
Indications for Use Form
510(k) Number (if known): K113082
Sonovision v2.0 Device Name:
Indications for Use:
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, 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
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