K113082 · Peridot Technologies Ny, Inc. · LLZ · Mar 8, 2012 · Radiology
Device Facts
Record ID
K113082
Device Name
SONOVISION
Applicant
Peridot Technologies Ny, Inc.
Product Code
LLZ · Radiology
Decision Date
Mar 8, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
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.
Device Story
Sonovision 2.0 is an ultrasound workstation software application. It captures images and video clips from ultrasound machines and other medical imaging systems. The software saves data to a local database, supports DICOM conversion, and enables integration with PACS servers. It provides tools for image review, including zooming, panning, flipping, rotating, brightness/contrast adjustment, and text annotation. Users can also create DICOM CDs/DVDs or print images. The device is intended for use by clinicians and technicians in hospitals, imaging labs, and medical offices. It facilitates study management and reporting, allowing healthcare providers to review and archive patient ultrasound data to support clinical decision-making.
Clinical Evidence
No clinical data. The submission relies on bench testing and functional verification of software features, including image acquisition, DICOM compatibility, and workstation management tools, to demonstrate substantial equivalence.
Technological Characteristics
Software application for commercial off-the-shelf (COTS) hardware. Features include image/video capture, DICOM conversion, PACS integration, and local database management. Supports lossless (uncompressed) storage in local database; manual conversion to DICOM/JPG/PNG may apply lossy compression. Image processing tools include zoom, pan, flip, rotate, and annotation. Connectivity via network interfaces for PACS. No specific algorithm architecture or hardware-specific sensing mentioned.
Indications for Use
Indicated for obstetricians, gynecologists, radiologists, ultrasound technicians, and cardiologists for the acquisition, management, reporting, and archiving of ultrasound images and study data in clinical settings (hospitals, imaging labs, medical offices).
Regulatory Classification
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.
Special Controls
*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).
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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,<br>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.
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| Manufacturer | Device Name | 510(k) Number | Clearance Date |
|---------------------------------|-----------------------------|---------------|----------------|
| AS Software Inc. | AS-OBGYN Information System | K051639 | Aug 02, 2005 |
| Ashva Technologies<br>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<br>Brightness/Contrast/Text<br>Annotations | Zoom/Pan | Zoom/Pan/Flip/Rotate<br>Brightness/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 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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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
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Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
